Deep Brain Stimulation of the Globus Pallidus in Huntington's Disease

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Completed

CT.gov ID

NCT00902889

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Huntington's Disease	Procedure: Stimulation Procedure: Stimulation	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Single Centre (Pilot) Study for Deep Brain Stimulation (DBS) of the Globus Pallidus in Huntington's Disease (HD)

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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) Other Names: GPI GPE
Experimental: 2 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) Other Names: GPE GPI

Arm

Intervention/Treatment

Experimental: 1

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)

Other Names:

GPI

GPE

Experimental: 2

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)

Other Names:

GPE

GPI

Outcome Measures

Primary Outcome Measures

Efficacy of stimulation of GPI versus GPR (UHDRS Scale) [3 months after stimulation treatment]

Secondary Outcome Measures

Effect of treatment on cognitive functions (neuropsychological tests) [3 months after stimulation treatment]
Effects of treatment on electrophysiological tests [3 months after stimulation treatment]
Effects of treatment on functional scale (functional ability, dependence scale, TFC) [3 months after stimulation treatment]
Progression of disease (motor UHDRS) [12 months after stimulation treatment]
Effect of treatment on striatal atrophy (CT Scans) [3 months after stimulation treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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