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 : July 30, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Huntington Disease | Device: ACTIVA® PC neurostimulator (Model 37601) | Not Applicable |
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 |

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))
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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 |
- 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.
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Susanne Harnisch | +49 6421 2866553 | susanne.harnisch@kks.uni-marburg.de | |
Contact: Pauline Kleger | +49 731 50063106 | Pauline.Kleger@uniklinik-ulm.de |
Austria | |
Medizinische Universität Innsbruck | Recruiting |
Innsbruck, Austria, 6020 | |
Contact: Klaus Seppi, Prof Dr + 43 (0)512 504-25810 klaus.seppi@tirol-kliniken.at | |
Contact: Marina Peball, Dr. +43 512 504/82718 marina.peball@tirol-kliniken.at | |
France | |
CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology | Recruiting |
Amiens, France, 80054 | |
Contact: Pierre Krystkowiak, Prof +33322668240 krystkowiak.pierre@chu-amiens.fr | |
Contact: Michel Lefranc, Dr Lefranc.Michel@chu-amiens.fr | |
Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement | Recruiting |
Lille Cedex, France, 59037 | |
Contact: Clemence Simonin, Dr. +33 3.20.44.67.52 clemence.simonin@chru-lille.fr | |
Contact: Eric Decorte +33 03.20.44.59.62 eric.decorte@chru-lille.fr | |
Germany | |
Charité Campus Virchow Klinikum | Recruiting |
Berlin, Germany, 13353 | |
Contact: Andrea Kühn, Prof Dr 030 450 660203 andrea.kuehn@charite.de | |
Contact: Mandy Schickor +49 (0)30 450 660 478 Mandy.Schickor@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 |
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: | July 30, 2018 |
Last Verified: | July 2018 |
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 |