Deep Brain Stimulation (DBS) of the Globus pallidus (GP) in Huntington’s disease (HD): A prospective, randomised, controlled, international, multi-centre study
- Conditions
- G10Huntington disease
- Registration Number
- DRKS00006785
- Lead Sponsor
- niversität Düsseldorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
•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
•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 baseline
•Cortical atrophy grade 3
•Patients with risk of coagulopathies and/or increased risk of haemorrhage
•Patients with an implanted pacemaker or defibrillator
•Pregnancy
•lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference between the groups in the UHDRS (Unified Huntingon's Disease Rating Scale) total motor score (UHDRS-TMS) at 12 weeks postoperatively compared to baseline .
- Secondary Outcome Measures
Name Time Method