G10
Conditions
Interventions
Group 1: Pallidal deep brain stimulation during the whole study (2x12weeks)
Group 2: No pallidal deep brain stimulation for 12 weeks following 12 weeks with stimulation.
Sponsors
Universität Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Motor function: -Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20) -Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29) -Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score -Difference in the Q-Motor "choreomotography” test (Reilmann Battery) -Difference in the Q-Motor “digitomotography” test (Reilmann Battery) i.Digitomotography – IOI-variability ii.Dysdiadochomotography – IOI-variability iii.Manumotography – GFV iv.Choreomotography – Orientation-index v.Pedomotography – IOI-variability Cognition: -Difference in the Mattis Dementia Rating Scale (MDRS) -Difference in the Verbal Fluency Test (formal lexical, categorical, category change) -Difference in the Symbol Digit Modalities Test (SDMT) -Difference in STROOP word reading, colour naming and colour of the word naming Psychiatry / Emotion: -Difference in the Hospital Anxiety and Depression Scale combined with Snaith Irritability Scale (HADS-SIS) -Difference in the Problem Behaviours Assessment Short Form (PBA-s) Quality of Life: -Difference in the Short Form (36) Health Survey (SF-36) -Difference in the Clinical Global Impression Scale (CGI) | — |
Primary
| Measure | Time frame |
|---|---|
| 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 . | — |
Countries
Austria, France, Germany
Contacts
Public ContactJan Vesper
Funktionelle Neurochirurgie und StereotaxieNeurochirurgische Klinik,Universitätsklinikum DüsseldorfAmbulanz/Sekr.: +49 211 81 16058
Outcome results
None listed