I changed the captions in the Wedding Album. I got off dead links on my link page.
Thursday, June 4, 2009
Coenzyme Q10 in Huntington's Disease (HD)
Coenzyme Q10 in Huntington's Disease (HD)
This study is currently recruiting participants.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), January 2009
First Received: February 4, 2008 Last Updated: January 14, 2009
This study is currently recruiting participants.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), January 2009
First Received: February 4, 2008 Last Updated: January 14, 2009
University of Rochester
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00608881
Purpose
The goals of this trial are to determine if coenzyme Q10 is effective in slowing the worsening symptoms of Huntington's disease and to learn about the safety and acceptability of long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.
Condition
Intervention
Phase
Huntington's Disease
Drug: coenzyme Q10Other: placebo
Phase III
Study Type:
Interventional
Study Design:
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:
Coenzyme Q10 in Huntington's Disease (HD)
Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):
Primary Outcome Measures:
Change in total functional capacity [ Time Frame: over 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Change in other UHDRS scores; Tolerability - proportion of subjects completing the study at the assigned dosage level; Safety - frequency of adverse events; Times to decline in TFC by 2 and 3 points [ Time Frame: duration of the trial ] [ Designated as safety issue: Yes ]
Estimated Enrollment:
608
Study Start Date:
March 2008
Estimated Study Completion Date:
April 2014
Estimated Primary Completion Date:
April 2014 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
A: Active Comparator
Randomized to active treatment (coenzyme Q10 2400 mg/day)
Drug: coenzyme Q10
4 - 300 mg CoQ chewable wafers taken orally twice a day
B: Placebo Comparator
Randomized to placebo
Other: placebo
an inactive substance Detailed Description:
Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available.
The purpose of this trial is to find out if coenzyme Q10 (CoQ) is effective in slowing the worsening symptoms of HD. In this study, researchers also will learn about the safety and acceptability of long-term CoQ use by determining its effects on people with HD.
Participants in this trial will be randomly chosen to one of two groups. Group 1 will receive CoQ (2400 mg/day), and group 2 will receive a placebo (an inactive substance). Researchers will compare the change in total functional capacity (TFC)—a measure of functional disability—in the two groups. The TFC is a valid and reliable measure of disease progression and is particularly responsive to change in the early and mid-stages of HD. Researchers will also compare the changes in other components of the Unified Huntington's Disease Rating Scale '99 (UHDRS) including: the total motor score, total behavioral frequency score, total behavior frequency X severity score, verbal fluency test, symbol digit modalities test, Stroop, interference test, functional checklist, and independence scale scores. The groups will also be compared with respect to tolerability, adverse events, vital signs, and laboratory test results as measures of safety.
Eligibility
Ages Eligible for Study:
16 Years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
To be eligible for enrollment into this study, subjects must meet the following eligibility criteria within 28 days prior to randomization:
Subjects must have clinical features of HD and a confirmed family history of HD, OR a CAG repeat expansion ≥ 36.
TFC > 9.
Must be ambulatory and not require skilled nursing care.
Age ≥ 16 years.
Women must not be able to become pregnant (e.g., post menopausal, surgically sterile or using adequate birth control methods for the duration of the study).
If psychotropic medications are taken (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants), they must be at a stable dosage for four weeks prior to randomization and should be maintained at a constant dosage throughout the study, as possible. Any changes to these medications mandated by clinical conditions will be systematically recorded and the subject will be permitted to remain in the trial.
Able to give informed consent and comply with trial procedures
Able to take oral medication.
Able to identify an informant or caregiver who will be willing and able to supervise the daily dosing of study medications and to maintain control of study medications in the home.
A designated individual will be identified by the subject to participate in the ongoing consent process should the subject's cognitive capacity to consent become compromised during participation in the study.
Exclusion Criteria:
History or known sensitivity of intolerability to CoQ.
Exposure to any investigational drug within 30 days of the Baseline visit.
Clinical evidence of unstable medical illness in the investigator's judgment.
Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression or suicidal ideation within 90 days of the Baseline visit.
Substance (alcohol or drug) abuse within one year of the Baseline visit.
Women who are pregnant or breastfeeding.
Use of supplemental coenzyme Q10 within 120 days prior to the Baseline visit
Clinically serious abnormalities in the screening laboratory studies (Screening creatinine greater than 2.0, alanine aminotransferase (ALT) or total bilirubin greater than 3 times the upper limit of normal, absolute neutrophil count of ≤1000/ul, platelet concentration of <100,000/ul,> 1.5 time upper limit of normal).
Known allergy to FD&C yellow #5 or any other ingredient in the study drug (active and placebo)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608881
Contacts
Contact: Huntington Study Group
1-800-487-7671
Show 43 Study Locations
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Investigators
Principal Investigator:
Merit Cudkowicz, MD MSc
Massachusetts General Hospital
Principal Investigator:
Michael McDermott, PhD
University of Rochester, Biostatistics
Principal Investigator:
Karl Kieburtz, MD MPH
Director, Clinical Trials Coordination Center, University of Rochester
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00608881
Purpose
The goals of this trial are to determine if coenzyme Q10 is effective in slowing the worsening symptoms of Huntington's disease and to learn about the safety and acceptability of long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.
Condition
Intervention
Phase
Huntington's Disease
Drug: coenzyme Q10Other: placebo
Phase III
Study Type:
Interventional
Study Design:
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:
Coenzyme Q10 in Huntington's Disease (HD)
Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):
Primary Outcome Measures:
Change in total functional capacity [ Time Frame: over 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Change in other UHDRS scores; Tolerability - proportion of subjects completing the study at the assigned dosage level; Safety - frequency of adverse events; Times to decline in TFC by 2 and 3 points [ Time Frame: duration of the trial ] [ Designated as safety issue: Yes ]
Estimated Enrollment:
608
Study Start Date:
March 2008
Estimated Study Completion Date:
April 2014
Estimated Primary Completion Date:
April 2014 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
A: Active Comparator
Randomized to active treatment (coenzyme Q10 2400 mg/day)
Drug: coenzyme Q10
4 - 300 mg CoQ chewable wafers taken orally twice a day
B: Placebo Comparator
Randomized to placebo
Other: placebo
an inactive substance Detailed Description:
Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available.
The purpose of this trial is to find out if coenzyme Q10 (CoQ) is effective in slowing the worsening symptoms of HD. In this study, researchers also will learn about the safety and acceptability of long-term CoQ use by determining its effects on people with HD.
Participants in this trial will be randomly chosen to one of two groups. Group 1 will receive CoQ (2400 mg/day), and group 2 will receive a placebo (an inactive substance). Researchers will compare the change in total functional capacity (TFC)—a measure of functional disability—in the two groups. The TFC is a valid and reliable measure of disease progression and is particularly responsive to change in the early and mid-stages of HD. Researchers will also compare the changes in other components of the Unified Huntington's Disease Rating Scale '99 (UHDRS) including: the total motor score, total behavioral frequency score, total behavior frequency X severity score, verbal fluency test, symbol digit modalities test, Stroop, interference test, functional checklist, and independence scale scores. The groups will also be compared with respect to tolerability, adverse events, vital signs, and laboratory test results as measures of safety.
Eligibility
Ages Eligible for Study:
16 Years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
To be eligible for enrollment into this study, subjects must meet the following eligibility criteria within 28 days prior to randomization:
Subjects must have clinical features of HD and a confirmed family history of HD, OR a CAG repeat expansion ≥ 36.
TFC > 9.
Must be ambulatory and not require skilled nursing care.
Age ≥ 16 years.
Women must not be able to become pregnant (e.g., post menopausal, surgically sterile or using adequate birth control methods for the duration of the study).
If psychotropic medications are taken (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants), they must be at a stable dosage for four weeks prior to randomization and should be maintained at a constant dosage throughout the study, as possible. Any changes to these medications mandated by clinical conditions will be systematically recorded and the subject will be permitted to remain in the trial.
Able to give informed consent and comply with trial procedures
Able to take oral medication.
Able to identify an informant or caregiver who will be willing and able to supervise the daily dosing of study medications and to maintain control of study medications in the home.
A designated individual will be identified by the subject to participate in the ongoing consent process should the subject's cognitive capacity to consent become compromised during participation in the study.
Exclusion Criteria:
History or known sensitivity of intolerability to CoQ.
Exposure to any investigational drug within 30 days of the Baseline visit.
Clinical evidence of unstable medical illness in the investigator's judgment.
Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression or suicidal ideation within 90 days of the Baseline visit.
Substance (alcohol or drug) abuse within one year of the Baseline visit.
Women who are pregnant or breastfeeding.
Use of supplemental coenzyme Q10 within 120 days prior to the Baseline visit
Clinically serious abnormalities in the screening laboratory studies (Screening creatinine greater than 2.0, alanine aminotransferase (ALT) or total bilirubin greater than 3 times the upper limit of normal, absolute neutrophil count of ≤1000/ul, platelet concentration of <100,000/ul,> 1.5 time upper limit of normal).
Known allergy to FD&C yellow #5 or any other ingredient in the study drug (active and placebo)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608881
Contacts
Contact: Huntington Study Group
1-800-487-7671
Show 43 Study Locations
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Investigators
Principal Investigator:
Merit Cudkowicz, MD MSc
Massachusetts General Hospital
Principal Investigator:
Michael McDermott, PhD
University of Rochester, Biostatistics
Principal Investigator:
Karl Kieburtz, MD MPH
Director, Clinical Trials Coordination Center, University of Rochester
Posted by Heather Dugdale at 2:11 PM 0 comments
Deep Brain Stimulation of the Globus Pallidus in Huntington's Disease
Deep Brain Stimulation of the Globus Pallidus in Huntington's Disease
This study is currently recruiting participants.
Verified by Heinrich-Heine University, Duesseldorf, January 2009
First Received: May 14, 2009 No Changes Posted
Sponsored by:
Heinrich-Heine University, Duesseldorf
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00902889
Purpose
This is a single centre, controlled phase I study, which evaluates safety and efficacy of stimulation of lower caudal two contacts (GPI) vs. upper cranial two contacts (GPE) in Huntington´s disease (HD).
Condition
Intervention
Phase
Huntington's Disease
Procedure: Stimulation
Phase I
Interventional
Study Design:
Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:
Single Centre (Pilot) Study for Deep Brain Stimulation (DBS) of the Globus Pallidus in Huntington's Disease (HD)
Further study details as provided by Heinrich-Heine University, Duesseldorf:
Primary Outcome Measures:
Efficacy of stimulation of GPI versus GPR (UHDRS Scale) [ Time Frame: 3 months after stimulation treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Effect of treatment on cognitive functions (neuropsychological tests) [ Time Frame: 3 months after stimulation treatment ] [ Designated as safety issue: No ]
Effects of treatment on electrophysiological tests [ Time Frame: 3 months after stimulation treatment ] [ Designated as safety issue: No ]
Effects of treatment on functional scale (functional ability, dependence scale, TFC) [ Time Frame: 3 months after stimulation treatment ] [ Designated as safety issue: No ]
Progression of disease (motor UHDRS) [ Time Frame: 12 months after stimulation treatment ] [ Designated as safety issue: No ]
Effect of treatment on striatal atrophy (CT Scans) [ Time Frame: 3 months after stimulation treatment ] [ Designated as safety issue: No ]
Estimated Enrollment:
6
Study Start Date:
May 2009
Estimated Study Completion Date:
April 2011
Estimated Primary Completion Date:
April 2010 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
1: Experimental
6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation with GPE (upper cranial two contacts).
Procedure: Stimulation
6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation GPE (upper cranial two contacts)
2: Experimental
6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts)
Procedure: Stimulation
6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts) Detailed Description:
A total of 6 HD patients will be selected out of an existing larger HD patient cohort upon careful evaluation of the inclusion and exclusion criteria at month 0. Patients will be recruited if no significant cognitive deterioration is observed between month 0 and month 3. The preoperative clinical status will be evaluated twice including the United Huntington Disease Rating Scale (UHDRS), neuropsychological, neurophysiologic and neuroradiological assessments. At 4 weeks postoperatively an extensive evaluation of effects and side effects of every single contact of the bilateral quadripolar electrodes takes place.
All patients will receive a stereotactic placement of bilateral stereotactic insertion of two quadripolar electrodes into the Globus pallidus, two contacts reaching the GPE, two the GPI within both hemispheres. Surgery will be done under general anesthesia, The implantation of the stimulator (Kintera®) will take place in the same procedure. Postoperatively patients will be monitored at three and six months and regularly up to 60 months with a battery of clinical, neuropsychological, psychiatric, neurophysiological and neuroimaging tests.
We expect that this trial will provide a rational basis to conclude about the efficacy, safety, reproducibility and long-term effects of pallidal Deep Brain Stimulation (DBS) on motor symptoms of HD.
Eligibility
Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats>= 36)
age: > 18
moderate stage of the disease (UHDRS motor>= 30)
predominant movement disorder
compliance of the patient, stable cognition during a 6 months phase prior to inclusion (MDS>/= 120)
signed informed consent
Exclusion Criteria:
advanced disease, precluding the ability to give informed consent
very early stage of disease causing minor disability
severe comorbidity that could compromise the life prognostic or preclude general anaesthesia or immunosuppression
Mattis Dementia Rating Scale < 120
psychiatric or personality disturbances that might compromise the follow-up
participation at another trial (in particular transplantation)
severe cortical atrophy seen on CT and MRI
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902889
Contacts
Contact: Jan Vesper, Prof. Dr.
0049 211 8118408
jan.vesper@uniklinik-duesseldorf.de
Contact: Alfons Schnitzler, Prof. Dr.
0049 211 8117893
SchnitzA@med.uni-duesseldorf.de
Locations
Germany, NW
Functional Neurosurgery and Stereotaxy, Department of Neurosurgery University Hospital Duesseldorf
Recruiting
Duesseldorf, NW, Germany, 40225
Contact: Jan Vesper, Prof. Dr. 0049 221 8118408
jan.vesper@uniklinik-duesseldorf.de
Contact: Alfons Schnitzler, Prof. Dr. 0049 221 8117893
Contact: Alfons Schnitzler, Prof. Dr. 0049 221 8117893
SchnitzA@med.uni-duesseldorf.de
Principal Investigator: Jan Vester, Prof. Dr.
Sub-Investigator: Alfons Schnitzler, Prof. Dr.
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator:
Jan Vesper, Prof. Dr.
Functional Neurosurgery and Stereotaxy, Department of Neurosurgery
More Information
Publications:
Temel Y, Cao C, Vlamings R, Blokland A, Ozen H, Steinbusch HW, Michelsen KA, von Hörsten S, Schmitz C, Visser-Vandewalle V. Motor and cognitive improvement by deep brain stimulation in a transgenic rat model of Huntington's disease. Neurosci Lett. 2006 Oct 2;406(1-2):138-41. Epub 2006 Aug 14.
Responsible Party:
Heinrich Heine University, Duesseldorf, Functional Neurosurgery and Stereotaxy, Department of Neurosurgery ( Prof. Dr. Jan Vesper )
Study ID Numbers:
Huntington
Study First Received:
May 14, 2009
Last Updated:
May 14, 2009
ClinicalTrials.gov Identifier:
NCT00902889
Principal Investigator: Jan Vester, Prof. Dr.
Sub-Investigator: Alfons Schnitzler, Prof. Dr.
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator:
Jan Vesper, Prof. Dr.
Functional Neurosurgery and Stereotaxy, Department of Neurosurgery
More Information
Publications:
Temel Y, Cao C, Vlamings R, Blokland A, Ozen H, Steinbusch HW, Michelsen KA, von Hörsten S, Schmitz C, Visser-Vandewalle V. Motor and cognitive improvement by deep brain stimulation in a transgenic rat model of Huntington's disease. Neurosci Lett. 2006 Oct 2;406(1-2):138-41. Epub 2006 Aug 14.
Responsible Party:
Heinrich Heine University, Duesseldorf, Functional Neurosurgery and Stereotaxy, Department of Neurosurgery ( Prof. Dr. Jan Vesper )
Study ID Numbers:
Huntington
Study First Received:
May 14, 2009
Last Updated:
May 14, 2009
ClinicalTrials.gov Identifier:
NCT00902889
History of Changes
Health Authority:
Germany: Ethics CommissionKeywords provided by Heinrich-Heine University, Duesseldorf:
Globus pallidusHuntington's DiseaseDeep Brain StimulationMovement Disorders
Health Authority:
Germany: Ethics CommissionKeywords provided by Heinrich-Heine University, Duesseldorf:
Globus pallidusHuntington's DiseaseDeep Brain StimulationMovement Disorders
Posted by Heather Dugdale at 2:01 PM 0 comments
UK HD Events
June 2009
8th - 14th
HD Awareness Week - A series of national and local events will take place during our Awareness Week this year. Please check our online calendar in the lead up to Awareness Week for more information.
8th - 14th
HD Awareness Week - A series of national and local events will take place during our Awareness Week this year. Please check our online calendar in the lead up to Awareness Week for more information.
8th
An Inspirational Approach To Huntington’s Disease - With guest speaker Jim Pollard. Directory of Social Change, 24 Stephenson Way, London, NW1 2DP. 10.30am to 4.00pm -
9th
Palliative Care in Huntington’s Disease - Professional Study Day. To be held at The Kings Fund, 11-13 Cavendish Square, London, W1G 0AN -
Huntington’s Disease Family Day - The aim of the day is to provide people affected by Huntington’s disease with an opportunity to meet each other and to help them gain information. To be held at PJ Care, 1 Sherwood Place, 153, Sherwood Drive, Bletchley, Milton Keynes, MK3 6RT -
July/August 2009
17th - 19th31st - 2nd
HDA Activity Weekends
Avon Tyrrell Activity Centre, New ForestMepal Outdoor Centre, CambridgeshireLledar Hall Outdoor Education Centre, North Wales
Sign up early to take part in our Activity Weekends during 2009, for children aged 9 to 16 years - download booking form
October 2009
2nd - 4th
HDA Annual General Meeting and Family Conference weekend
The AGM and Family Conference will take place at the Park Inn Hotel, Telford, Shropshire. More information and a booking form will be sent out with our June 2009 newsletter and will be available to download from our website from mid-June onwards.
Posted by Heather Dugdale at 12:29 PM 0 comments
Wednesday, June 3, 2009
Dad and brother visting
My Dad and Brother are coming down after my Nero appt. We have that on the 30 th of June. Gary will come back for a week. My Dad will come, stay, and pick Gary up. Today I pulled a muscle doing Tee Ball. They did not do a warm up and my leg got pulled. I am still hoping to Relay for Life. Even if I am sore. I will still do it. I will never give up. never give up either. Do what you want. Do not let anything get in your way. Achieve your dreams. Anything is possible. Just set your eyes and achieve.
Posted by Heather Dugdale at 6:42 PM 0 comments
Effects of Music Therapy on Huntington's Disease
Effects of Music Therapy on Huntington's Disease
This study is currently recruiting participants.
Verified by University of Rochester, September 2005
First Received: September 12, 2005 Last Updated: April 14, 2006
This study is currently recruiting participants.
Verified by University of Rochester, September 2005
First Received: September 12, 2005 Last Updated: April 14, 2006
History of Changes
Sponsored by:
University of Rochester
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178360
Purpose
The purpose of this study is primarily to assess the ability of a music therapy program to improve holistically the psychological, somatic, and social symptoms of patients with Huntington ’s disease (HD). We hope to demonstrate the benefits of applying music therapy interventions to the management methods of HD, thus paving the way for the development of an effective music therapy program for individuals with HD.
Condition
Intervention
Phase
Huntington's Disease
Behavioral: Music Therapy
Phase I
Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome
MedlinePlus related topics: Huntington's Disease Hurricanes
U.S. FDA Resources
Study Type:
Interventional
Study Design:
Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:
The Effects of Music Therapy on Depression, Chorea and Other Symptoms of Huntington's Disease
Further study details as provided by University of Rochester:
Primary Outcome Measures:
To examine the feasibility and tolerability of a treatment program of MT for subjects with HD.
Secondary Outcome Measures:
To determine if MT improves the mood and motor features of HD while improving quality of life.
Estimated Enrollment:
25
Study Start Date:
July 2004
Estimated Study Completion Date:
July 2005Detailed Description:
ABSTRACT
Background: Recent studies show that music therapy helps improve the symptomatic manifestations of Parkinson’s Disease. Few studies have looked at music therapy as a treatment for the psychiatric, cognitive and motor symptoms of patients with Huntington’s disease (HD).
Objective: To examine the feasibility and tolerability of a treatment program of music therapy for patients with Huntington’s disease. Also, to determine if music therapy improves the mood and motor features of HD while improving quality of life.
Methods: Subjects with HD were recruited to participate in a six-week study that included one individual, half-hour music therapy session and one hour-long group session per week. The music therapy protocols were adapted from the Colorado State University’s Neurological Music Therapy program and were targeted to HD symptoms including balance and posture, fine motor skills, memory and attention, vocalizations, and mood. In particular the protocols included Rhythmic Auditory Stimulation (RAS), Pattern Sensory Enhancement (PSE), and Therapeutic Instrumental Music Playing (TIMP). Primary outcome of tolerability was to be assessed by the subjects’ adherence to the therapeutic protocol, attendance, and the results of an exit survey inquiring about their feelings toward the use of music therapy in HD. A secondary outcome of the study was the change in the Unified Huntington’s Disease Rating Scale (UHDRS) score between baseline and study completion.
Results: Five subjects were recruited for study participation (one female and four males). Music therapy was found to be a tolerable and feasible treatment for patients with HD (100% adherence and 98% attendance). Exit surveys demonstrated strongly positive feelings towards the music therapy treatment program in four of the five subjects (one survey was completed with contradictory answers by the subject). While there was improvement in UHDRS scores for finger tapping, pronation/supination and the Luria, these changes did not achieve statistical significance with the small sample size in this study.
Conclusions: Music therapy was well tolerated among subjects with HD in this small study. Future studies are now being planned to look at the efficacy of this intervention in a larger population of HD subjects.
Eligibility
Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
Diagnosis of HD
Over the age of 18
Patients must be ambulatory, use of a walker or human support is acceptable
Patients must be able to communicate their thoughts and feelings
Exclusion Criteria:
Anyone without the preceding characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178360
Contacts
Contact: Rosemary Oliva, BM
585-273-2098
mailto:Rosemary_Oliva%40urmc.rochester.edu?subject=NCT00178360,
Contact: Olle Jane Z Sahler, MD
585-275-3935
mailto:OJ_Sahler%40urmc.rochester.edu?subject=NCT00178360,
Locations
United States, New York
University of Rochester Medical Center
Recruiting
Rochester, New York, United States, 14642
Contact: Olle Jane Z Sahler, MD 585-275-3935 mailto:OJ_Sahler%40urmc.rochester.edu?subject=NCT00178360,
Contact: Rosemary Oliva, BM 585-273-2098 mailto:Rosemary_Oliva%40urmc.rochester.edu?subject=NCT00178360,
Sub-Investigator: Bryan C Hunter, PhD
Sub-Investigator: H. Christopher Hyson, MD
Sub-Investigator: Rosemary Oliva, BM
Sub-Investigator: Kori A LaDonna, BA
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator:
Olle Jane Z Sahler, MD
University of Rochester
More Information
Additional Information:
American Music Therapy Association Home Page
Huntington's Disease Society of America Home Page
Huntington's Disease Society of America - Upstate New York Chapter Home Page No publications provided
Study ID Numbers:
10336
Study First Received:
September 12, 2005
Last Updated:
April 14, 2006
ClinicalTrials.gov Identifier:
NCT00178360
Sponsored by:
University of Rochester
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178360
Purpose
The purpose of this study is primarily to assess the ability of a music therapy program to improve holistically the psychological, somatic, and social symptoms of patients with Huntington ’s disease (HD). We hope to demonstrate the benefits of applying music therapy interventions to the management methods of HD, thus paving the way for the development of an effective music therapy program for individuals with HD.
Condition
Intervention
Phase
Huntington's Disease
Behavioral: Music Therapy
Phase I
Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome
MedlinePlus related topics: Huntington's Disease Hurricanes
U.S. FDA Resources
Study Type:
Interventional
Study Design:
Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:
The Effects of Music Therapy on Depression, Chorea and Other Symptoms of Huntington's Disease
Further study details as provided by University of Rochester:
Primary Outcome Measures:
To examine the feasibility and tolerability of a treatment program of MT for subjects with HD.
Secondary Outcome Measures:
To determine if MT improves the mood and motor features of HD while improving quality of life.
Estimated Enrollment:
25
Study Start Date:
July 2004
Estimated Study Completion Date:
July 2005Detailed Description:
ABSTRACT
Background: Recent studies show that music therapy helps improve the symptomatic manifestations of Parkinson’s Disease. Few studies have looked at music therapy as a treatment for the psychiatric, cognitive and motor symptoms of patients with Huntington’s disease (HD).
Objective: To examine the feasibility and tolerability of a treatment program of music therapy for patients with Huntington’s disease. Also, to determine if music therapy improves the mood and motor features of HD while improving quality of life.
Methods: Subjects with HD were recruited to participate in a six-week study that included one individual, half-hour music therapy session and one hour-long group session per week. The music therapy protocols were adapted from the Colorado State University’s Neurological Music Therapy program and were targeted to HD symptoms including balance and posture, fine motor skills, memory and attention, vocalizations, and mood. In particular the protocols included Rhythmic Auditory Stimulation (RAS), Pattern Sensory Enhancement (PSE), and Therapeutic Instrumental Music Playing (TIMP). Primary outcome of tolerability was to be assessed by the subjects’ adherence to the therapeutic protocol, attendance, and the results of an exit survey inquiring about their feelings toward the use of music therapy in HD. A secondary outcome of the study was the change in the Unified Huntington’s Disease Rating Scale (UHDRS) score between baseline and study completion.
Results: Five subjects were recruited for study participation (one female and four males). Music therapy was found to be a tolerable and feasible treatment for patients with HD (100% adherence and 98% attendance). Exit surveys demonstrated strongly positive feelings towards the music therapy treatment program in four of the five subjects (one survey was completed with contradictory answers by the subject). While there was improvement in UHDRS scores for finger tapping, pronation/supination and the Luria, these changes did not achieve statistical significance with the small sample size in this study.
Conclusions: Music therapy was well tolerated among subjects with HD in this small study. Future studies are now being planned to look at the efficacy of this intervention in a larger population of HD subjects.
Eligibility
Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
Diagnosis of HD
Over the age of 18
Patients must be ambulatory, use of a walker or human support is acceptable
Patients must be able to communicate their thoughts and feelings
Exclusion Criteria:
Anyone without the preceding characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178360
Contacts
Contact: Rosemary Oliva, BM
585-273-2098
mailto:Rosemary_Oliva%40urmc.rochester.edu?subject=NCT00178360,
Contact: Olle Jane Z Sahler, MD
585-275-3935
mailto:OJ_Sahler%40urmc.rochester.edu?subject=NCT00178360,
Locations
United States, New York
University of Rochester Medical Center
Recruiting
Rochester, New York, United States, 14642
Contact: Olle Jane Z Sahler, MD 585-275-3935 mailto:OJ_Sahler%40urmc.rochester.edu?subject=NCT00178360,
Contact: Rosemary Oliva, BM 585-273-2098 mailto:Rosemary_Oliva%40urmc.rochester.edu?subject=NCT00178360,
Sub-Investigator: Bryan C Hunter, PhD
Sub-Investigator: H. Christopher Hyson, MD
Sub-Investigator: Rosemary Oliva, BM
Sub-Investigator: Kori A LaDonna, BA
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator:
Olle Jane Z Sahler, MD
University of Rochester
More Information
Additional Information:
American Music Therapy Association Home Page
Huntington's Disease Society of America Home Page
Huntington's Disease Society of America - Upstate New York Chapter Home Page No publications provided
Study ID Numbers:
10336
Study First Received:
September 12, 2005
Last Updated:
April 14, 2006
ClinicalTrials.gov Identifier:
NCT00178360
Keywords provided by University of Rochester:
Huntington's Disease, Music Therapy, quality of life
Huntington's Disease, Music Therapy, quality of life
Posted by Heather Dugdale at 2:43 PM 0 comments
Subscribe to:
Posts (Atom)
