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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00006785 | Registry Identifier | Deutsches Register Klinischer Studien |
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| Name | Class |
|---|---|
| KKS Netzwerk | NETWORK |
| Medtronic | INDUSTRY |
| The George Institute | OTHER |
| Egyptian Society of Neurological Surgeons |
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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
In this study the efficacy and safety of pallidal Deep Brain Stimulation (DBS) in HD patients shall be investigated and superiority of DBS on motor function in the stimulation group compared to the stimulation-off group shall be shown. This study is a prospective, randomised, double blind, parallel group, sham-controlled, multi-centre trial. Patients in the stimulation group will be stimulated for three months while the stimulator in the sham-group will be turned off for three months. After three months the primary endpoint will be assessed. Afterwards the stimulator will be turned on in all patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation group | Experimental | Patients in the stimulation group will be stimulated immediately after implantation of the Stimulator (ACTIVA® PC neurostimulator (Model 37601)) |
|
| Non-stimulation group | Sham Comparator | 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)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTIVA® PC neurostimulator (Model 37601) | Device | the stimulator in the stimulation group will be turned on after implantation of the device |
|
| Measure | Description | Time Frame |
|---|---|---|
| UHDRS-TMS difference | Difference between the groups in the UHDRS total motor score (UHDRS-TMS) at 12 weeks postoperatively compared to baseline. | 12 weeks postoperatively compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| UHDRS-Chorea difference | Difference in the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore (items 14-20) | 6 months postoperatively compared to baseline |
| UHDRS-bradykinesia difference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Vesper, Prof Dr. | Dept. of Functional Neurosurgery and Stereotaxy | Study Chair |
| Alfons Schnitzler, Prof Dr | Dept.of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria | |||
| CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15293283 | Background | 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. | |
| Background | 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. | ||
| 19050408 |
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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.
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| OTHER |
| CHDI Foundation, Inc. | OTHER |
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.
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Difference in the UHDRS bradykinesia subscore (items 22-25 and 27-29)
| 6 months postoperatively compared to baseline |
| BFMDRS difference | Difference in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) motor score | 6 months postoperatively compared to baseline |
| Reilmann Battery differences | Difference in the Q-Motor "choreomotography" test (Reilmann Battery) | 6 months postoperatively compared to baseline |
| MDRS difference | Difference in the Mattis Dementia Rating Scale (MDRS) | 6 months postoperatively compared to baseline |
| Verbal Fluency Test difference | Difference in the Verbal Fluency Test (formal lexical, categorical, category change) | 6 months postoperatively compared to baseline |
| SDMT difference | Difference in the Symbol Digit Modalities Test (SDMT) | 6 months postoperatively compared to baseline |
| STROOP Test differences | Difference in STROOP word reading, colour naming and colour of the word naming | 6 months postoperatively compared to baseline |
| HADS-SIS difference | Difference in the Hospital Anxiety and Depression Scale combined with Snaith Irritability Scale (HADS-SIS) | 6 months postoperatively compared to baseline |
| PBA-s difference | Difference in the Problem Behaviours Assessment Short Form (PBA-s) | 6 months postoperatively compared to baseline |
| SF 36 difference | Difference in the Short Form (36) Health Survey (SF-36) | 6 months postoperatively compared to baseline |
| CGI difference | Difference in the Clinical Global Impression Scale (CGI) | 6 months postoperatively compared to baseline |
| Amiens |
| 80054 |
| France |
| Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement | Lille | 59037 | France |
| Charité Campus Virchow Klinikum | Berlin | 13353 | Germany |
| University hospital Heinrich Heine University Düsseldorf | Düsseldorf | 40225 | Germany |
| University Hospital Freiburg | Freiburg im Breisgau | 79106 | Germany |
| University Hospital Schleswig-Holstein | Kiel | 24105 | Germany |
| Universität zu Lübeck | Lübeck | 23562 | Germany |
| University hospital Munich LMU | Munich | 80336 | Germany |
| kbo-Isar-Amper-Clinic Taufkirchen | Taufkirchen | 84416 | Germany |
| Center for Neurology | Bern | Gümlingen | 3073 | Switzerland |
| Inselspital, Department of Neurology | Bern | 3010 | Switzerland |
| Background |
| 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. |
| 26347707 | Background | 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. |
| 27589813 | Background | 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. |
| 35766355 | Derived | 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. |
| 31381524 | Derived | 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. |
| 27230813 | Derived | 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. |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D002819 | Chorea |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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