Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease
NCT ID: NCT05394688
Last Updated: 2023-09-28
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
20 participants
OBSERVATIONAL
2022-01-01
2022-12-31
Brief Summary
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Detailed Description
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The following data will collected: the scores of Unified Parkinson's disease questionnaire part III (UPDRS-III), Non-Motor Symptoms Questionnaire (NMS-quest), Beck Depression Inventory (BDI), Mini-Mental State Examination (MMSE), Abnormal Involuntary Movement Scale (AIMS) evaluated in the screening phase for dDBS treatment and at 6-months' follow-up. Possible levodopa equivalent dose changes, LEDDs, will also be assessed at these time points.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Hospital District of Helsinki and Uusimaa
OTHER
Responsible Party
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Maija Koivu
M.D., Specialist in Neurology
Principal Investigators
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Eero Pekkonen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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HUH Meilahti Hospital, department of neurology
Helsinki, , Finland
Countries
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References
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Weaver FM, Follett K, Stern M, Hur K, Harris C, Marks WJ Jr, Rothlind J, Sagher O, Reda D, Moy CS, Pahwa R, Burchiel K, Hogarth P, Lai EC, Duda JE, Holloway K, Samii A, Horn S, Bronstein J, Stoner G, Heemskerk J, Huang GD; CSP 468 Study Group. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial. JAMA. 2009 Jan 7;301(1):63-73. doi: 10.1001/jama.2008.929.
Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, Voges J; German Parkinson Study Group, Neurostimulation Section. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. doi: 10.1056/NEJMoa060281.
Steigerwald F, Muller L, Johannes S, Matthies C, Volkmann J. Directional deep brain stimulation of the subthalamic nucleus: A pilot study using a novel neurostimulation device. Mov Disord. 2016 Aug;31(8):1240-3. doi: 10.1002/mds.26669. Epub 2016 May 31.
Dembek TA, Reker P, Visser-Vandewalle V, Wirths J, Treuer H, Klehr M, Roediger J, Dafsari HS, Barbe MT, Timmermann L. Directional DBS increases side-effect thresholds-A prospective, double-blind trial. Mov Disord. 2017 Oct;32(10):1380-1388. doi: 10.1002/mds.27093. Epub 2017 Aug 26.
Contarino MF, Bour LJ, Verhagen R, Lourens MA, de Bie RM, van den Munckhof P, Schuurman PR. Directional steering: A novel approach to deep brain stimulation. Neurology. 2014 Sep 23;83(13):1163-9. doi: 10.1212/WNL.0000000000000823. Epub 2014 Aug 22.
Schnitzler A, Mir P, Brodsky MA, Verhagen L, Groppa S, Alvarez R, Evans A, Blazquez M, Nagel S, Pilitsis JG, Potter-Nerger M, Tse W, Almeida L, Tomycz N, Jimenez-Shahed J, Libionka W, Carrillo F, Hartmann CJ, Groiss SJ, Glaser M, Defresne F, Karst E, Cheeran B, Vesper J; PROGRESS Study Investigators. Directional Deep Brain Stimulation for Parkinson's Disease: Results of an International Crossover Study With Randomized, Double-Blind Primary Endpoint. Neuromodulation. 2022 Aug;25(6):817-828. doi: 10.1111/ner.13407. Epub 2022 Feb 2.
Rammo RA, Ozinga SJ, White A, Nagel SJ, Machado AG, Pallavaram S, Cheeran BJ, Walter BL. Directional Stimulation in Parkinson's Disease and Essential Tremor: The Cleveland Clinic Experience. Neuromodulation. 2022 Aug;25(6):829-835. doi: 10.1111/ner.13374. Epub 2022 Jun 14.
Other Identifiers
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HospitalIDHU
Identifier Type: -
Identifier Source: org_study_id
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