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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
the stimulator in the stimulation group will be turned on after implantation of the device
Medizinische Universität Innsbruck
Innsbruck, Austria
CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology
Amiens, France
Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement
Lille, France
UHDRS-TMS difference
Difference between the groups in the UHDRS total motor score (UHDRS-TMS) at 12 weeks postoperatively compared to baseline.
Time frame: 12 weeks postoperatively compared to baseline
UHDRS-Chorea difference
Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20)
Time frame: 6 months postoperatively compared to baseline
UHDRS-bradykinesia difference
Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29)
Time frame: 6 months postoperatively compared to baseline
BFMDRS difference
Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score
Time frame: 6 months postoperatively compared to baseline
Reilmann Battery differences
Difference in the Q-Motor "choreomotography" test (Reilmann Battery)
Time frame: 6 months postoperatively compared to baseline
MDRS difference
Difference in the Mattis Dementia Rating Scale (MDRS)
Time frame: 6 months postoperatively compared to baseline
Verbal Fluency Test difference
Difference in the Verbal Fluency Test (formal lexical, categorical, category change)
Time frame: 6 months postoperatively compared to baseline
SDMT difference
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Charité Campus Virchow Klinikum
Berlin, Germany
University hospital Heinrich Heine University Düsseldorf
Düsseldorf, Germany
University Hospital Freiburg
Freiburg im Breisgau, Germany
University Hospital Schleswig-Holstein
Kiel, Germany
Universität zu Lübeck
Lübeck, Germany
University hospital Munich LMU
Munich, Germany
kbo-Isar-Amper-Clinic Taufkirchen
Taufkirchen, Germany
...and 2 more locations
Difference in the Symbol Digit Modalities Test (SDMT)
Time frame: 6 months postoperatively compared to baseline
STROOP Test differences
Difference in STROOP word reading, colour naming and colour of the word naming
Time frame: 6 months postoperatively compared to baseline
HADS-SIS difference
Difference in the Hospital Anxiety and Depression Scale combined with Snaith Irritability Scale (HADS-SIS)
Time frame: 6 months postoperatively compared to baseline
PBA-s difference
Difference in the Problem Behaviours Assessment Short Form (PBA-s)
Time frame: 6 months postoperatively compared to baseline
SF 36 difference
Difference in the Short Form (36) Health Survey (SF-36)
Time frame: 6 months postoperatively compared to baseline
CGI difference
Difference in the Clinical Global Impression Scale (CGI)
Time frame: 6 months postoperatively compared to baseline