Randomized Controlled Trial Comparing Imaging-based Programming With Threshold-assessment Based Programming of Deep Brain Stimulation for Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this single-center prospective, randomized, open-label clinical trial is to compare the effectiveness of imaging-based DBS programming with threshold assessment-based DBS programming in patients with Parkinson's disease and motor response fluctuations. The main question the study aims to answer is: Is the improvement of motor symptoms in the OFF-drug phase following STN DBS for Parkinson's disease, using imaging-based DBS programming only, non-inferior to the improvement of motor symptoms following DBS programming with threshold assessment at six months follow-up? Participants will be randomized to imaging-based programming or to threshold assessment-based programming. The main clinical outcome is motor symptoms; secondary outcomes are level of physical disability and quality of life, among others.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Parkinson's disease diagnosis based on the clinical diagnostic criteria of Movement Disorder Society

• Scheduled for DBS screening

• Age of 18 years or older

• Understand the Dutch language

Locations
Other Locations
Netherlands
Amsterdam UMC location AMC
RECRUITING
Amsterdam
Contact Information
Primary
Annabel van der Weide, MA
a.vanderweide@amsterdamumc.nl
+31-20-5663943
Time Frame
Start Date: 2024-01-03
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 132
Treatments
Experimental: Imaging-based
66 patients with Parkinson's disease will receive imaging-based DBS programming
Active_comparator: Threshold assessment-based
66 patients with Parkinson's disease will receive DBS programming based on the threshold assessment
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov

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