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

Huntington's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902889
• Other study ID #: Huntington
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2009
• Last updated: September 10, 2012
• Start date: May 2009
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

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

Locations

Country	Name	City	State
Germany	Functional Neurosurgery and Stereotaxy, Department of Neurosurgery University Hospital Duesseldorf	Duesseldorf	NW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of stimulation of GPI versus GPR (UHDRS Scale)		3 months after stimulation treatment	Yes
Secondary	Effect of treatment on cognitive functions (neuropsychological tests)		3 months after stimulation treatment	No
Secondary	Effects of treatment on electrophysiological tests		3 months after stimulation treatment	No
Secondary	Effects of treatment on functional scale (functional ability, dependence scale, TFC)		3 months after stimulation treatment	No
Secondary	Progression of disease (motor UHDRS)		12 months after stimulation treatment	No
Secondary	Effect of treatment on striatal atrophy (CT Scans)		3 months after stimulation treatment	No