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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02535884
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : January 21, 2022
Sponsor:
Collaborators:
KKS Netzwerk
Medtronic
The George Institute
Egyptian Society of Neurological Surgeons
CHDI Foundation, Inc.
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Huntington Disease Device: ACTIVA® PC neurostimulator (Model 37601) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD): A Prospective, Randomised, Controlled, International, Multi-centre Study
Actual Study Start Date : July 2014
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stimulation group
Patients in the stimulation group will be stimulated immediately after implantation of the Stimulator (ACTIVA® PC neurostimulator (Model 37601))
Device: ACTIVA® PC neurostimulator (Model 37601)
the stimulator in the stimulation group will be turned on after implantation of the device

Sham Comparator: Non-stimulation group
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))
Device: ACTIVA® PC neurostimulator (Model 37601)
the stimulator in the stimulation group will be turned on after implantation of the device




Primary Outcome Measures :
  1. UHDRS-TMS difference [ Time Frame: 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 :
  1. UHDRS-Chorea difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20)

  2. UHDRS-bradykinesia difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29)

  3. BFMDRS difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score

  4. Reilmann Battery differences [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Q-Motor "choreomotography" test (Reilmann Battery)

  5. MDRS difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Mattis Dementia Rating Scale (MDRS)

  6. Verbal Fluency Test difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Verbal Fluency Test (formal lexical, categorical, category change)

  7. SDMT difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Symbol Digit Modalities Test (SDMT)

  8. STROOP Test differences [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in STROOP word reading, colour naming and colour of the word naming

  9. HADS-SIS difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Hospital Anxiety and Depression Scale combined with Snaith Irritability Scale (HADS-SIS)

  10. PBA-s difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Problem Behaviours Assessment Short Form (PBA-s)

  11. SF 36 difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Short Form (36) Health Survey (SF-36)

  12. CGI difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Clinical Global Impression Scale (CGI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535884


Locations
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Austria
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
France
CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology
Amiens, France, 80054
Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement
Lille Cedex, France, 59037
Germany
Charité Campus Virchow Klinikum
Berlin, Germany, 13353
University hospital Heinrich Heine University Düsseldorf
Düsseldorf, Germany, 40225
University Hospital Freiburg
Freiburg, Germany, 79106
University Hospital Schleswig-Holstein
Kiel, Germany, 24105
Universität zu Lübeck
Lubeck Hansestadt, Germany, 23562
University hospital Munich LMU
Munich, Germany, 80336
kbo-Isar-Amper-Clinic Taufkirchen
Taufkirchen, Germany, 84416
Switzerland
Center for Neurology
Bern, Gümlingen, Switzerland, 3073
Inselspital, Department of Neurology
Bern, Switzerland, 3010
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
KKS Netzwerk
Medtronic
The George Institute
Egyptian Society of Neurological Surgeons
CHDI Foundation, Inc.
Investigators
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Study Chair: Jan Vesper, Prof Dr. Dept. of Functional Neurosurgery and Stereotaxy
Principal Investigator: Alfons Schnitzler, Prof Dr Dept.of Neurology
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02535884    
Other Study ID Numbers: KKS-198
DRKS00006785 ( Registry Identifier: Deutsches Register Klinischer Studien )
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study the data will be provided to the CHDI. The Foundation may use, and make available for use by the Foundation Collaborators, the Study Data for the following purposes: (A) to design and guide future research studies and clinical trials and (B) to support and enable the following scientific discussion and research: (1) to better understand HD or other diseases being studied, (2) that furthers the development of treatments for HD or other diseases or (3) that furthers biomedical research.
Keywords provided by Heinrich-Heine University, Duesseldorf:
Huntington Disease
DBS
Chorea
Additional relevant MeSH terms:
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Huntington Disease
Brain Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders