Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease
dDBS
1 other identifier
observational
20
1 country
1
Brief Summary
The aim of the study is to assess the clinical outcome in patients with Parkinson's disease treated with directional deep brain stimulation (dDBS). The patients have been selected for the dDBS treatment by their treating neurologist. The study is a registry-based follow-up study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2020
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 28, 2023
September 1, 2023
3 months
September 28, 2020
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The actual use of directional DBS stimulation in everyday life during the follow-up
The use of directionality in DBS in patients with PD in everyday life
6-18 months
Secondary Outcomes (4)
The changes of UPDRS part III score during the DBS treatment
From the initiation of DBS treatment to 18-month's postoperative visit
Evaluation of the dDBS parameters
6 months to 18 months
Possible adverse effects
6 months-18 months
LEDDs
From preoperative visit to 18 month's postoperative visit
Eligibility Criteria
Study population will consist of the initial 63 patients with Parkinson'd disease treated with directional deep brain stimulation in Helsinki University Hospital
You may qualify if:
- Patients with advanced Parkinson's disease and treated with directional deep brain stimulation
You may not qualify if:
- patients with advanced Parkinson's disease and not treated with directional deeb brain stimulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HUH Meilahti Hospital, department of neurology
Helsinki, 00029, Finland
Related Publications (7)
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.
PMID: 19126811BACKGROUNDDeuschl 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.
PMID: 16943402BACKGROUNDSteigerwald 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.
PMID: 27241197RESULTDembek 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.
PMID: 28843009RESULTContarino 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.
PMID: 25150285RESULTSchnitzler 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.
PMID: 34047410RESULTRammo 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.
PMID: 33733515RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eero Pekkonen, MD, PhD
Helsinki University Central Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Specialist in Neurology
Study Record Dates
First Submitted
September 28, 2020
First Posted
May 27, 2022
Study Start
January 1, 2022
Primary Completion
April 12, 2022
Study Completion
December 31, 2022
Last Updated
September 28, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share