Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD)
NCT ID: NCT02535884
Last Updated: 2022-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2014-07-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Stimulation group
Patients in the stimulation group will be stimulated immediately after implantation of the Stimulator (ACTIVA® PC neurostimulator (Model 37601))
ACTIVA® PC neurostimulator (Model 37601)
the stimulator in the stimulation group will be turned on after implantation of the device
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))
ACTIVA® PC neurostimulator (Model 37601)
the stimulator in the stimulation group will be turned on after implantation of the device
Interventions
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ACTIVA® PC neurostimulator (Model 37601)
the stimulator in the stimulation group will be turned on after implantation of the device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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KKS Netzwerk
NETWORK
Medtronic
INDUSTRY
The George Institute
OTHER
Egyptian Society of Neurological Surgeons
OTHER
CHDI Foundation, Inc.
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Principal Investigators
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Jan Vesper, Prof Dr.
Role: STUDY_CHAIR
Dept. of Functional Neurosurgery and Stereotaxy
Alfons Schnitzler, Prof Dr
Role: PRINCIPAL_INVESTIGATOR
Dept.of Neurology
Locations
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Medizinische Universität Innsbruck
Innsbruck, , Austria
CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology
Amiens, , France
Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement
Lille, , France
Charité Campus Virchow Klinikum
Berlin, , Germany
University hospital Heinrich Heine University Düsseldorf
Düsseldorf, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
University Hospital Schleswig-Holstein
Kiel, , Germany
Universität zu Lübeck
Lübeck, , Germany
University hospital Munich LMU
Munich, , Germany
kbo-Isar-Amper-Clinic Taufkirchen
Taufkirchen, , Germany
Center for Neurology
Bern, Gümlingen, Switzerland
Inselspital, Department of Neurology
Bern, , Switzerland
Countries
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References
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Moro E, Lang AE, Strafella AP, Poon YY, Arango PM, Dagher A, Hutchison WD, Lozano AM. Bilateral globus pallidus stimulation for Huntington's disease. Ann Neurol. 2004 Aug;56(2):290-4. doi: 10.1002/ana.20183.
Groiss SJ WL, Suedmeyer, M, Ploner M, Reck C, Voges J, SturmV, Timmermann L, Schnitzler A. Effect of bilateral pallidal deep brain stimulation in Huntington's disease: A case report. Mov Disord, Volume 21, Issue S15. Tenth International Congress of Parkinson's Disease and Movement Disorders. Kyoto 2006.
Fasano A, Cadeddu F, Guidubaldi A, Piano C, Soleti F, Zinzi P, Bentivoglio AR. The long-term effect of tetrabenazine in the management of Huntington disease. Clin Neuropharmacol. 2008 Nov-Dec;31(6):313-8. doi: 10.1097/WNF.0b013e318166da60.
Wojtecki L, Groiss SJ, Ferrea S, Elben S, Hartmann CJ, Dunnett SB, Rosser A, Saft C, Sudmeyer M, Ohmann C, Schnitzler A, Vesper J; Surgical Approaches Working Group of the European Huntington's Disease Network (EHDN). A Prospective Pilot Trial for Pallidal Deep Brain Stimulation in Huntington's Disease. Front Neurol. 2015 Aug 18;6:177. doi: 10.3389/fneur.2015.00177. eCollection 2015.
Wojtecki L, Groiss SJ, Hartmann CJ, Elben S, Omlor S, Schnitzler A, Vesper J. Deep Brain Stimulation in Huntington's Disease-Preliminary Evidence on Pathophysiology, Efficacy and Safety. Brain Sci. 2016 Aug 30;6(3):38. doi: 10.3390/brainsci6030038.
Kinfe T, Del Vecchio A, Nussel M, Zhao Y, Stadlbauer A, Buchfelder M. Deep brain stimulation and stereotactic-assisted brain graft injection targeting fronto-striatal circuits for Huntington's disease: an update. Expert Rev Neurother. 2022 Sep;22(9):781-788. doi: 10.1080/14737175.2022.2091988. Epub 2022 Jun 29.
Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.
Hartmann CJ, Groiss SJ, Vesper J, Schnitzler A, Wojtecki L. Brain stimulation in Huntington's disease. Neurodegener Dis Manag. 2016 Jun;6(3):223-36. doi: 10.2217/nmt-2016-0007. Epub 2016 May 27.
Other Identifiers
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DRKS00006785
Identifier Type: REGISTRY
Identifier Source: secondary_id
KKS-198
Identifier Type: -
Identifier Source: org_study_id
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