Trial document




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  DRKS00006785

Trial Description

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Title

Deep Brain Stimulation (DBS) of the Globus pallidus (GP) in Huntington’s disease (HD): A prospective, randomised, controlled, international, multi-centre study

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Trial Acronym

HD-DBS

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to prove the efficacy and safety of deep brain stimulation in patients with Huntington Disease. At present, there is no effective treatment or cure for HD patients. Therefore several groups looked for alternatives, utilising Deep Brain stimulation, based on the long-lasting successful treatment of other neurodegenerative movement disorders like Parkinson’s disease.
Two groups will be compared. Patients in both groups will be implanted with 2 electrodes in the brain. One group will immediately be stimulated for 12 weeks, in the other group the stimulator will only be switched on after these 12 weeks, to test the effect difference after this time. During the first 12 weeks neither the patients nor the physicians know , in which group the patients are. After this time the allocation will be unblinded and both groups will be followed for further 12 weeks in the study.

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Brief Summary in Scientific Language

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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006785
  •   2014/09/24
  •   2015/08/28
  •   yes
  •   Approved
  •   MPG-LKP-24, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  •   NCT02535884  (ClinicalTrials.gov)
  •   CIV-13-12-011770 
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Health Condition or Problem studied

  •   G10 -  Huntington disease
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Interventions/Observational Groups

  •   Pallidal deep brain stimulation during the whole study (2x12weeks)
  •   No pallidal deep brain stimulation for 12 weeks following 12 weeks with stimulation.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Difference between the groups in the UHDRS (Unified Huntingon's Disease Rating Scale) total motor score (UHDRS-TMS) at 12 weeks postoperatively compared to baseline .

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Secondary Outcome

Motor function:
-Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20)
-Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29)
-Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score
-Difference in the Q-Motor "choreomotography” test (Reilmann Battery)
-Difference in the Q-Motor “digitomotography” test (Reilmann Battery)
i.Digitomotography – IOI-variability
ii.Dysdiadochomotography – IOI-variability
iii.Manumotography – GFV
iv.Choreomotography – Orientation-index
v.Pedomotography – IOI-variability
Cognition:
-Difference in the Mattis Dementia Rating Scale (MDRS)
-Difference in the Verbal Fluency Test (formal lexical, categorical, category change)
-Difference in the Symbol Digit Modalities Test (SDMT)
-Difference in STROOP word reading, colour naming and colour of the word naming
Psychiatry / Emotion:
-Difference in the Hospital Anxiety and Depression Scale combined with Snaith Irritability Scale (HADS-SIS)
-Difference in the Problem Behaviours Assessment Short Form (PBA-s)
Quality of Life:
-Difference in the Short Form (36) Health Survey (SF-36)
-Difference in the Clinical Global Impression Scale (CGI)

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Countries of Recruitment

  •   Germany
  •   Austria
  •   France
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/03/18
  •   50
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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 baseline
•Cortical atrophy grade 3
•Patients with risk of coagulopathies and/or increased risk of haemorrhage
•Patients with an implanted pacemaker or defibrillator
•Pregnancy
•lactation

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Addresses

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    • Universität Düsseldorf
    • Heinrich-Heine-Universität Düsseldorf Universitätsstr. 1
    • 40225  Düsseldorf
    • Germany
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    • Koordinierungszentrum für Klinische Studien Marburg
    • Ms.  Carmen  Schade Brittinger 
    • Karl-von-Frisch-Strasse 4
    • 35043  Marburg
    • Germany
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    • Koordinierungszentrum für Klinische StudienUniversitätsklinikum Düsseldorf
    • Ms.  Henrike   Kolbe 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Medtronic GmbH
    • Mr.  Dr.  David   Keller 
    • Earl-Bakken-Platz 1
    • 40670   Meerbusch
    • Germany
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    • CHDI Foundation
    • Ms.  Christina  Sampaio 
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    • Funktionelle Neurochirurgie und StereotaxieNeurochirurgische Klinik,Universitätsklinikum DüsseldorfAmbulanz/Sekr.: +49 211 81 16058
    • Mr.  Prof Dr.  Jan  Vesper 
    • Moorenstr. 5
    • D-40225  Düsseldorf
    • Germany
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    • Funktionelle Neurochirurgie und StereotaxieNeurochirurgische Klinik,Universitätsklinikum DüsseldorfAmbulanz/Sekr.: +49 211 81 16058
    • Mr.  Prof Dr.  Jan  Vesper 
    • Moorenstr. 5
    • D-40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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    • CHDI Foundation
    • Ms.  Christina  Sampaio 
    • 6080 Center Drive Suite
    • 100  Los Angeles, California, 90045, United States
    • United States
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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