Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease

Parkinson Disease Clinical Trial

— dDBS  

Official title:

Directional Deep Brain Stimulation in Advanced Parkinson's Disease - Clinical Review

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05394688
• Other study ID #: HospitalIDHU
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Hospital District of Helsinki and Uusimaa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The study group consists of patients with advanced Parkinson's disease treated with directional deep brain stimulation in Helsinki University Hospital between 2017 - 2020. The study is a registry-based follow-up study. The aim of the study is to assess the clinical outcome and possible adverse effects of the dDBS treatment. The data will be collected from the patient records. The observed time points are 6-month's, 12-month's and 18-month's postoperative visits.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with advanced Parkinson's disease and treated with directional deep brain stimulation

Exclusion Criteria:

• patients with advanced Parkinson's disease and not treated with directional deeb brain stimulation

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Finland	HUH Meilahti Hospital, department of neurology	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Hospital District of Helsinki and Uusimaa

Country where clinical trial is conducted

Finland, 

References & Publications (7)

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. — View Citation

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/m — View Citation

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. Erratum In: N Engl J Med. 2006 Sep 21;355(12):1289. — View Citation

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. — View Citation

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, Chee — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The changes of UPDRS part III score during the DBS treatment	The changes of UPDRS part III score during the DBS treatment	From the initiation of DBS treatment to 18-month's postoperative visit
Secondary	Evaluation of the dDBS parameters	The use of dDBS, active contacts and the dDBS programming protocol will be studied.	6 months to 18 months
Secondary	Possible adverse effects	Possible adverse effects of dDBS operation and treatment will be collected	6 months-18 months
Secondary	LEDDs	Possible changes of levodopa equivalent doses, LEDDs, are studied	From preoperative visit to 18 month's postoperative visit