Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD): A Prospective, Randomised, Controlled, International, Multi-centre Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Huntington Disease
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Enrollment
- 48
- Locations
- 12
- Primary Endpoint
- UHDRS-TMS difference
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of the study is to prove the efficacy and safety of pallidal DBS in HD patients and to show superiority of DBS on motor function in the stimulation group compared to stimulation-off group
Detailed Description
In this study the efficacy and safety of pallidal Deep Brain Stimulation (DBS) in HD patients shall be investigated and superiority of DBS on motor function in the stimulation group compared to the stimulation-off group shall be shown. This study is a prospective, randomised, double blind, parallel group, sham-controlled, multi-centre trial. Patients in the stimulation group will be stimulated for three months while the stimulator in the sham-group will be turned off for three months. After three months the primary endpoint will be assessed. Afterwards the stimulator will be turned on in all patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinically symptomatic and genetically confirmed HD (number of CAG repeats ≥ 36)
- •Age ≥18 years
- •Moderate stage of the disease (UHDRS motor score ≥ 30)
- •Chorea despite best medical treatment (UHDRS chorea subscore ≥ 10)
- •Mattis Dementia Rating Scale ≥ 120 (or \> 80% of items testable independently from motor impairment)
- •Patient has stable medication prior six weeks before inclusion
- •Signed informed consent
Exclusion Criteria
- •Juvenile HD (Westphal variant) or predominant bradykinesia
- •Postural instability with UHDRS retropulsion score \> 2
- •Severe comorbidity compromising operability and/or life expectancy and/or quality of life during the trial duration (e.g. cancer with life expectancy \< 6 months, NYHA 3 and 4 rising the anaesthetic risk according to the anaesthesiologist)
- •Acute suicidality
- •Acute psychosis (symptoms within previous 6 months)
- •Participation in any interventional clinical trial within 2 months before screening
- •Cortical atrophy grade 3
- •Patients with risk of coagulopathies and/or increased risk of haemorrhage
- •Patients with an implanted pacemaker or defibrillator
- •Pregnancy
Outcomes
Primary Outcomes
UHDRS-TMS difference
Time Frame: 12 weeks postoperatively compared to baseline
Difference between the groups in the UHDRS total motor score (UHDRS-TMS) at 12 weeks postoperatively compared to baseline.
Secondary Outcomes
- UHDRS-bradykinesia difference(6 months postoperatively compared to baseline)
- HADS-SIS difference(6 months postoperatively compared to baseline)
- SF 36 difference(6 months postoperatively compared to baseline)
- UHDRS-Chorea difference(6 months postoperatively compared to baseline)
- BFMDRS difference(6 months postoperatively compared to baseline)
- Reilmann Battery differences(6 months postoperatively compared to baseline)
- MDRS difference(6 months postoperatively compared to baseline)
- PBA-s difference(6 months postoperatively compared to baseline)
- CGI difference(6 months postoperatively compared to baseline)
- Verbal Fluency Test difference(6 months postoperatively compared to baseline)
- STROOP Test differences(6 months postoperatively compared to baseline)
- SDMT difference(6 months postoperatively compared to baseline)