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

Primary Purpose

Huntington Disease

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

ACTIVA® PC neurostimulator (Model 37601)

About this trial

This is an interventional treatment trial for Huntington Disease focused on measuring Huntington Disease, DBS, Chorea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Medizinische Universität Innsbruck
CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology
Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement
Charité Campus Virchow Klinikum
University hospital Heinrich Heine University Düsseldorf
University Hospital Freiburg
University Hospital Schleswig-Holstein
Universität zu Lübeck
University hospital Munich LMU
kbo-Isar-Amper-Clinic Taufkirchen
Center for Neurology
Inselspital, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Stimulation group

Non-stimulation group

Arm Description

Patients in the stimulation group will be stimulated immediately after implantation of the Stimulator (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))

Outcomes

Primary Outcome Measures

UHDRS-TMS difference

Difference between the groups in the UHDRS total motor score (UHDRS-TMS) at 12 weeks postoperatively compared to baseline.

Secondary Outcome Measures

UHDRS-Chorea difference

Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20)

UHDRS-bradykinesia difference

Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29)

BFMDRS difference

Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score

Reilmann Battery differences

Difference in the Q-Motor "choreomotography" test (Reilmann Battery)

MDRS difference

Difference in the Mattis Dementia Rating Scale (MDRS)

Verbal Fluency Test difference

Difference in the Verbal Fluency Test (formal lexical, categorical, category change)

SDMT difference

Difference in the Symbol Digit Modalities Test (SDMT)

STROOP Test differences

Difference in STROOP word reading, colour naming and colour of the word naming

HADS-SIS difference

Difference in the Hospital Anxiety and Depression Scale combined with Snaith Irritability Scale (HADS-SIS)

PBA-s difference

Difference in the Problem Behaviours Assessment Short Form (PBA-s)

SF 36 difference

Difference in the Short Form (36) Health Survey (SF-36)

CGI difference

Difference in the Clinical Global Impression Scale (CGI)

Full Information

NCT ID

NCT02535884

First Posted

August 27, 2015

Last Updated

January 20, 2022

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

KKS Netzwerk, Medtronic, The George Institute, Egyptian Society of Neurological Surgeons, CHDI Foundation, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02535884

Brief Title

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

Acronym

HD-DBS

Official Title

Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD): A Prospective, Randomised, Controlled, International, Multi-centre Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

July 2014 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

KKS Netzwerk, Medtronic, The George Institute, Egyptian Society of Neurological Surgeons, CHDI Foundation, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Huntington Disease

Keywords

Huntington Disease, DBS, Chorea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

During the first 3 month the one group will be stimulated (pallidal DBS), thereafter 12 weeks open follow up, where patients in both groups are stimulated.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stimulation group

Arm Type

Experimental

Arm Description

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

Arm Title

Non-stimulation group

Arm Type

Sham Comparator

Arm 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))

Intervention Type

Device

Intervention Name(s)

ACTIVA® PC neurostimulator (Model 37601)

Intervention Description

the stimulator in the stimulation group will be turned on after implantation of the device

Primary Outcome Measure Information:

Title

UHDRS-TMS difference

Description

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

Secondary Outcome Measure Information:

Title

UHDRS-Chorea difference

Description

Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20)

Time Frame