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Trial record 84 of 193 for:    "huntington disease"

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 : August 6, 2019
Sponsor:
Collaborators:
KKS Netzwerk
Medtronic
The George Institute
EHDN
CHDI Foundation, Inc.
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Tracking Information
First Submitted Date  ICMJE August 27, 2015
First Posted Date  ICMJE August 31, 2015
Last Update Posted Date August 6, 2019
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
UHDRS-TMS difference [ Time Frame: 3 months ]
Difference between the groups in the UHDRS total motor score (UHDRS-TMS) at 12 weeks postoperatively compared to baseline.
Change History Complete list of historical versions of study NCT02535884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
  • 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)
  • UHDRS-bradykinesia difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29)
  • BFMDRS difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score
  • Reilmann Battery differences [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Q-Motor "choreomotography" test (Reilmann Battery)
  • MDRS difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Mattis Dementia Rating Scale (MDRS)
  • Verbal Fluency Test difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Verbal Fluency Test (formal lexical, categorical, category change)
  • SDMT difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Symbol Digit Modalities Test (SDMT)
  • STROOP Test differences [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in STROOP word reading, colour naming and colour of the word naming
  • 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)
  • PBA-s difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Problem Behaviours Assessment Short Form (PBA-s)
  • SF 36 difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Short Form (36) Health Survey (SF-36)
  • CGI difference [ Time Frame: 6 months postoperatively compared to baseline ]
    Difference in the Clinical Global Impression Scale (CGI)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • UHDRS-Chorea difference [ Time Frame: 6 months ]
    - Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20)
  • UHDRS-bradykinesia difference [ Time Frame: 6 months ]
    Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29)
  • BFMDRS difference [ Time Frame: 6 months ]
    Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score
  • Reilmann Battery differences [ Time Frame: 6 months ]
    Difference in the Q-Motor "choreomotography" test (Reilmann Battery)
  • MDRS difference [ Time Frame: 6 months ]
    Difference in the Mattis Dementia Rating Scale (MDRS)
  • Verbal Fluency Test difference [ Time Frame: 6 months ]
    Difference in the Verbal Fluency Test (formal lexical, categorical, category change)
  • SDMT difference [ Time Frame: 6 months ]
    Difference in the Symbol Digit Modalities Test (SDMT)
  • STROOP Test differences [ Time Frame: 6 months ]
    Difference in STROOP word reading, colour naming and colour of the word naming
  • HADS-SIS difference [ Time Frame: 6 months ]
    - Difference in the Hospital Anxiety and Depression Scale combined with Snaith Irritability Scale (HADS-SIS)
  • PBA-s difference [ Time Frame: 6 months ]
    Difference in the Problem Behaviours Assessment Short Form (PBA-s)
  • SF 36 difference [ Time Frame: 6 months ]
    Difference in the Short Form (36) Health Survey (SF-36)
  • CGI difference [ Time Frame: 6 months ]
    Difference in the Clinical Global Impression Scale (CGI)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD)
Official Title  ICMJE Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD): A Prospective, Randomised, Controlled, International, Multi-centre Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Huntington Disease
Intervention  ICMJE Device: ACTIVA® PC neurostimulator (Model 37601)
the stimulator in the stimulation group will be turned on after implantation of the device
Study Arms  ICMJE
  • Experimental: Stimulation group
    Patients in the stimulation group will be stimulated immediately after implantation of the Stimulator (ACTIVA® PC neurostimulator (Model 37601))
    Intervention: Device: ACTIVA® PC neurostimulator (Model 37601)
  • 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))
    Intervention: Device: ACTIVA® PC neurostimulator (Model 37601)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Susanne Harnisch +49 6421 2866553 susanne.harnisch@kks.uni-marburg.de
Contact: Jenny Townhill Jenny.Townhill@Enroll-HD.org
Listed Location Countries  ICMJE Austria,   France,   Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02535884
Other Study ID Numbers  ICMJE KKS-198
DRKS00006785 ( Registry Identifier: Deutsches Register Klinischer Studien )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Heinrich-Heine University, Duesseldorf
Study Sponsor  ICMJE Heinrich-Heine University, Duesseldorf
Collaborators  ICMJE
  • KKS Netzwerk
  • Medtronic
  • The George Institute
  • EHDN
  • CHDI Foundation, Inc.
Investigators  ICMJE
Study Chair: Jan Vesper, Prof Dr. Dept. of Functional Neurosurgery and Stereotaxy
Principal Investigator: Alfons Schnitzler, Prof Dr Dept.of Neurology
PRS Account Heinrich-Heine University, Duesseldorf
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP