Trial document

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DRKS-ID: 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

DRKS-ID: DRKS00006785
Date of Registration in DRKS: 2014/09/24
Date of Registration in Partner Registry or other Primary Registry: 2015/08/28
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: MPG-LKP-24, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf

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Secondary IDs

Primary Registry-ID: NCT02535884 (ClinicalTrials.gov)
EUDAMED-No. (for studies acc. to Medical Devices act): CIV-13-12-011770

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Health Condition or Problem studied

ICD10: G10 - Huntington disease

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Interventions/Observational Groups

Arm 1: Pallidal deep brain stimulation during the whole study (2x12weeks)
Arm 2: No pallidal deep brain stimulation for 12 weeks following 12 weeks with stimulation.

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject, investigator/therapist, caregiver, assessor, data analyst
Control: Placebo
Purpose: Treatment
Assignment: Parallel
Phase: N/A
Off-label Drug use: 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

DE: Germany
AT: Austria
FR: France

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Locations of Recruitment

University Medical Center Funktionelle Neurochirurgie und Stereotaxie Neurochirurgische Klinik,, Düsseldorf
University Medical Center Charité, University Medicine Berlin Department of Neurology Campus Virchow Klinikum, Berlin
University Medical Center Klinik für Neurochirurgie Abteilung Stereotaktische und Funktionelle Neurochirurgie , Freiburg im Breisgau
University Medical Center Klinikum Großhadern der Ludwig-Maximilians-Universität München, Neurochirurgischen Klinik, München
Medical Center kbo-Isar-Amper-Klinikum Taufkirchen (Vils) , Taufkirchen
University Medical Center Universitätsklinikum Schleswig-Holstein, Abteilung für Neurologie, Kiel
University Medical Center Universitätsklinik Neurologie INSELSPITAL, Universitätsspital Bern CH-3010 Bern, Bern
Medical Center Neurologiezentrum, Siloah, Aerztehaus, 3073 Gümligen, Gümlingen
University Medical Center Neurologie, Medizinische Universität, Anichstrasse 35, 6020 Innsbruck , Innsbruck
University Medical Center Institut für Neurogenetik und Klinik für Neurologie, Ratzeburger Allee 160 23538 Lübeck, Lübeck
Medical Center CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology, Amiens
Medical Center Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement, Lille

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2015/03/18
Target Sample Size: 50
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Universität Düsseldorf
- Heinrich-Heine-Universität Düsseldorf Universitätsstr. 1
- 40225 Düsseldorf
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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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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- Telephone: 06421 2866509
- Fax: 06421 2866517
- E-mail: carmen.brittinger at kks.uni-marburg.de
- URL: [---]*
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Collaborator, Other Address
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- Koordinierungszentrum für Klinische StudienUniversitätsklinikum Düsseldorf
- Ms. Henrike Kolbe
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
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- Telephone: 02118119700
- Fax: [---]*
- E-mail: Henrike.Kolbe at med.uni-duesseldorf.de
- URL: [---]*
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Collaborator, Other Address
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- Medtronic GmbH
- Mr. Dr. David Keller
- Earl-Bakken-Platz 1
- 40670 Meerbusch
- Germany
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- Telephone: + 49 160 93901008
- Fax: [---]*
- E-mail: david.keller at medtronic.com
- URL: [---]*
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Collaborator, Other Address
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- CHDI Foundation
- Ms. Christina Sampaio
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- Telephone: [---]*
- Fax: [---]*
- E-mail: Cristina.Sampaio at chdifoundation.org
- URL: [---]*
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Contact for Scientific Queries
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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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- Telephone: +49 211 81 18408
- Fax: +49 211 81 015 18408
- E-mail: jan.vesper at uniklinik-duesseldorf.de
- URL: [---]*
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Contact for Public Queries
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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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- Telephone: +49 211 81 18408
- Fax: +49 211 81 015 18408
- E-mail: jan.vesper at uniklinik-duesseldorf.de
- URL: [---]*
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Bundesministerium für Bildung und Forschung Dienstsitz Berlin
- Hannoversche Straße 28-30
- 10115 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.bmbf.de
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Private sponsorship (foundations, study societies, etc.)
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: Cristina.Sampaio at chdifoundation.org
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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