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

NCT ID: NCT00902889

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Huntington's Disease

Keywords

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Globus pallidus Huntington's Disease Deep Brain Stimulation Movement Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation with GPE (upper cranial two contacts).

Group Type EXPERIMENTAL

Stimulation

Intervention Type PROCEDURE

6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation GPE (upper cranial two contacts)

2

6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts)

Group Type EXPERIMENTAL

Stimulation

Intervention Type PROCEDURE

6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts)

Interventions

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Stimulation

6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation GPE (upper cranial two contacts)

Intervention Type PROCEDURE

Stimulation

6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts)

Intervention Type PROCEDURE

Other Intervention Names

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GPI GPE GPE GPI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Vesper, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Functional Neurosurgery and Stereotaxy, Department of Neurosurgery

Locations

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Functional Neurosurgery and Stereotaxy, Department of Neurosurgery University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Temel Y, Cao C, Vlamings R, Blokland A, Ozen H, Steinbusch HW, Michelsen KA, von Horsten 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. doi: 10.1016/j.neulet.2006.07.036. Epub 2006 Aug 14.

Reference Type BACKGROUND
PMID: 16905252 (View on PubMed)

Ferrea S, Groiss SJ, Elben S, Hartmann CJ, Dunnett SB, Rosser A, Saft C, Schnitzler A, Vesper J, Wojtecki L; Surgical Approaches Working Group of the European Huntington's Disease Network (EHDN). Pallidal deep brain stimulation in juvenile Huntington's disease: local field potential oscillations and clinical data. J Neurol. 2018 Jul;265(7):1573-1579. doi: 10.1007/s00415-018-8880-1. Epub 2018 May 3.

Reference Type DERIVED
PMID: 29725840 (View on PubMed)

Beste C, Muckschel M, Elben S, J Hartmann C, McIntyre CC, Saft C, Vesper J, Schnitzler A, Wojtecki L. Behavioral and neurophysiological evidence for the enhancement of cognitive control under dorsal pallidal deep brain stimulation in Huntington's disease. Brain Struct Funct. 2015 Jul;220(4):2441-8. doi: 10.1007/s00429-014-0805-x. Epub 2014 May 31.

Reference Type DERIVED
PMID: 24878825 (View on PubMed)

Other Identifiers

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Huntington

Identifier Type: -

Identifier Source: org_study_id