Trial document
DRKS00006785
Trial Description
Title
Deep Brain Stimulation (DBS) of the Globus pallidus (GP) in Huntington’s disease (HD): A prospective, randomised, controlled, international, multi-centre study
Trial Acronym
HD-DBS
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.
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.
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
Secondary IDs
- NCT02535884 (ClinicalTrials.gov)
- CIV-13-12-011770
Health Condition or Problem studied
- G10 - Huntington disease
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.
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, investigator/therapist, caregiver
- Placebo
- Treatment
- Parallel
- N/A
- N/A
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 .
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)
Countries of Recruitment
- Germany
- Austria
- France
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
Recruitment
- Actual
- 2015/03/18
- 50
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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
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
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
end of 1:1-Block address otherstart of 1:1-Block address contact other- 06421 2866509
- 06421 2866517
- carmen.brittinger at kks.uni-marburg.de
- [---]*
end of 1:1-Block address contact other -
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- Koordinierungszentrum für Klinische StudienUniversitätsklinikum Düsseldorf
- Ms. Henrike Kolbe
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 02118119700
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- Henrike.Kolbe at med.uni-duesseldorf.de
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- Medtronic GmbH
- Mr. Dr. David Keller
- Earl-Bakken-Platz 1
- 40670 Meerbusch
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- + 49 160 93901008
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- david.keller at medtronic.com
- [---]*
end of 1:1-Block address contact other -
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- CHDI Foundation
- Ms. Christina Sampaio
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
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- Cristina.Sampaio at chdifoundation.org
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end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Funktionelle Neurochirurgie und StereotaxieNeurochirurgische Klinik,Universitätsklinikum DüsseldorfAmbulanz/Sekr.: +49 211 81 16058
- Mr. Prof Dr. Jan Vesper
- Moorenstr. 5
- D-40225 Düsseldorf
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 211 81 18408
- +49 211 81 015 18408
- jan.vesper at uniklinik-duesseldorf.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Funktionelle Neurochirurgie und StereotaxieNeurochirurgische Klinik,Universitätsklinikum DüsseldorfAmbulanz/Sekr.: +49 211 81 16058
- Mr. Prof Dr. Jan Vesper
- Moorenstr. 5
- D-40225 Düsseldorf
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 211 81 18408
- +49 211 81 015 18408
- jan.vesper at uniklinik-duesseldorf.de
- [---]*
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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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- http://www.bmbf.de
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- CHDI Foundation
- Ms. Christina Sampaio
- 6080 Center Drive Suite
- 100 Los Angeles, California, 90045, United States
- United States
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- [---]*
- [---]*
- Cristina.Sampaio at chdifoundation.org
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Status
- Recruiting complete, follow-up complete
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- [---]*
- 2021/12/02
- 31
- 48
Trial Publications, Results and other Documents
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