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

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Huntington Disease

Treatments: Device: ACTIVA® PC neurostimulator (Model 37601)

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT02535884

KKS-198

DRKS00006785 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

Stimulation group

Experimental group

Description:

Patients in the stimulation group will be stimulated immediately after implantation of the Stimulator (ACTIVA® PC neurostimulator (Model 37601))

Treatment:

Device: ACTIVA® PC neurostimulator (Model 37601)

Non-stimulation group

Sham Comparator group

Description:

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))

Treatment:

Device: ACTIVA® PC neurostimulator (Model 37601)