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

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ClinicalTrials.gov Identifier: NCT02535884
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
KKS Netzwerk
Medtronic
The George Institute
EHDN
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Study Start Date : July 2014
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : October 31, 2020

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


Contacts
Contact: Susanne Harnisch +49 6421 2866553 susanne.harnisch@kks.uni-marburg.de
Contact: Pauline Kleger +49 731 50063106 Pauline.Kleger@uniklinik-ulm.de

Locations
Austria
Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Klaus Seppi, Prof Dr    + 43 (0)512 504-25810    klaus.seppi@tirol-kliniken.at   
Contact: Katherina Mair, Dr.    + 43 (0)512-504-81553    katherina.mair@tirol-kliniken.at   
Germany
Charité Campus Virchow Klinikum Recruiting
Berlin, Germany, 13353
Contact: Andrea Kühn, Prof Dr    030 450 660203    andrea.kuehn@charite.de   
Contact: Josef Priller, Prof Dr    +49 (0)30 450-517209    josef.priller@charite.de   
University hospital Heinrich Heine University Düsseldorf Recruiting
Düsseldorf, Germany, 40225
Contact: Jan Vesper, Prof Dr    +49 211 81 18408    jan.vesper@med.uni-duesseldorf.de   
Contact: Alfons Schnitzler, Prof Dr    +49 211 81 17893    Schnitza@med.uni-duesseldorf.de   
Principal Investigator: Lars Wojtecki, Dr.         
University Hospital Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Volker Coenen, Prof Dr    +4976127050630    volker.coenen@uniklinik-freiburg.de   
Contact: Eva Maria Wissner    +49 761 270-50670    eva-maria.wissner@uniklinik-freiburg.de   
University Hospital Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Karsten Witt, Dr    0431 500 23810    Steffen.Paschen@uksh.de   
Contact: Birte Hackelberg    0431-597 8519    birte.hackelberg@uksh.de   
Universität zu Lübeck Recruiting
Lubeck Hansestadt, Germany, 23562
Contact: Alexander Münchau, Prof Dr.    0451 31018215    alexander.muenchau@neuro.uni-luebeck.de   
Contact: Vera Tadic    0451 31018214    vera.tadic@neuro.uni-luebeck.de   
University hospital Munich LMU Recruiting
Munich, Germany, 80336
Contact: Jan Mehrkens, Dr    08970952698    jan.mehrkens@med.uni-muenchen.de   
Contact: Kai Bötzel, PD Dr    089 7095 3673    Kai.Boetzel@med.uni-muenchen.de   
kbo-Isar-Amper-Clinic Taufkirchen Recruiting
Taufkirchen, Germany, 84416
Contact: Ralf Marquard, Prof Dr    08084 934 495    Ralf.Marquard@kbo.de   
Contact: Erna Jobst    08084 934-307    erna.jobst@kbo.de   
Switzerland
Center for Neurology Recruiting
Bern, Gümlingen, Switzerland, 3073
Contact: Jean Marc Burgunder, Prof Dr    +41 031 352 20 70    jean-marc.burgunder@dkf.unibe.ch   
Contact: Michael Schüpbach    +41 316322168    wmms@bluewin.ch   
Inselspital, Department of Neurology Recruiting
Bern, Switzerland, 3010
Contact: Michael Schüpbach, PD Dr    +41 31 623 32 44    wmms@bluewin.ch   
Contact: Jean Marc Brugunder, Prof Dr.    +41 031 352 20 70    jmburgunder@bluewin.ch   
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
KKS Netzwerk
Medtronic
The George Institute
EHDN
CHDI Foundation, Inc.
Investigators
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):
Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02535884     History of Changes
Other Study ID Numbers: KKS-198
DRKS00006785 ( Registry Identifier: Deutsches Register Klinischer Studien )
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
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:
Huntington Disease
Basal Ganglia Diseases
Brain 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