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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00902889
First received: May 14, 2009
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 6
Study Start Date: May 2009
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
Germany
Functional Neurosurgery and Stereotaxy, Department of Neurosurgery University Hospital Duesseldorf
Duesseldorf, NW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Jan Vesper, Prof. Dr. Functional Neurosurgery and Stereotaxy, Department of Neurosurgery
  More Information

Publications:

Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT00902889     History of Changes
Other Study ID Numbers: Huntington
Study First Received: May 14, 2009
Last Updated: September 10, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Heinrich-Heine University, Duesseldorf:
Globus pallidus
Huntington's Disease
Deep Brain Stimulation
Movement Disorders

Additional relevant MeSH terms:
Brain Diseases
Huntington Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013