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

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

History of Changes
Health Authority:
Germany: Ethics CommissionKeywords provided by Heinrich-Heine University, Duesseldorf:
Globus pallidusHuntington's DiseaseDeep Brain StimulationMovement Disorders