Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD)

Not Applicable

Completed

• Conditions: Huntington Disease
• Interventions: Device: ACTIVA® PC neurostimulator (Model 37601)

• Registration Number: NCT02535884
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-08-31
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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
• lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-stimulation group	ACTIVA® PC neurostimulator (Model 37601)	Patients in the non-stimulation group will not be stimulated for the first three months after implantation of the Stimulator (ACTIVA® PC neurostimulator (Model 37601))
Stimulation group	ACTIVA® PC neurostimulator (Model 37601)	Patients in the stimulation group will be stimulated immediately after implantation of the Stimulator (ACTIVA® PC neurostimulator (Model 37601))

Primary Outcome Measures

Name	Time	Method
UHDRS-TMS difference	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 Outcome Measures

Name	Time	Method
UHDRS-bradykinesia difference	6 months postoperatively compared to baseline	Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29)
HADS-SIS difference	6 months postoperatively compared to baseline	Difference in the Hospital Anxiety and Depression Scale combined with Snaith Irritability Scale (HADS-SIS)
SF 36 difference	6 months postoperatively compared to baseline	Difference in the Short Form (36) Health Survey (SF-36)
UHDRS-Chorea difference	6 months postoperatively compared to baseline	Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20)
BFMDRS difference	6 months postoperatively compared to baseline	Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score
Reilmann Battery differences	6 months postoperatively compared to baseline	Difference in the Q-Motor "choreomotography" test (Reilmann Battery)
MDRS difference	6 months postoperatively compared to baseline	Difference in the Mattis Dementia Rating Scale (MDRS)
PBA-s difference	6 months postoperatively compared to baseline	Difference in the Problem Behaviours Assessment Short Form (PBA-s)
CGI difference	6 months postoperatively compared to baseline	Difference in the Clinical Global Impression Scale (CGI)
Verbal Fluency Test difference	6 months postoperatively compared to baseline	Difference in the Verbal Fluency Test (formal lexical, categorical, category change)
STROOP Test differences	6 months postoperatively compared to baseline	Difference in STROOP word reading, colour naming and colour of the word naming
SDMT difference	6 months postoperatively compared to baseline	Difference in the Symbol Digit Modalities Test (SDMT)

Trial Locations

Locations (12)

Charité Campus Virchow Klinikum; 🇩🇪 Berlin, Germany

Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement; 🇫🇷 Lille Cedex, France

CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology; 🇫🇷 Amiens, France

University hospital Heinrich Heine University Düsseldorf; 🇩🇪 Düsseldorf, Germany

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany

University hospital Munich LMU; 🇩🇪 Munich, Germany

Universität zu Lübeck; 🇩🇪 Lubeck Hansestadt, Germany

kbo-Isar-Amper-Clinic Taufkirchen; 🇩🇪 Taufkirchen, Germany

Center for Neurology; 🇨🇭 Bern, Gümlingen, Switzerland

Inselspital, Department of Neurology; 🇨🇭 Bern, Switzerland

University Hospital Freiburg; 🇩🇪 Freiburg, Germany

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria