Clinical Trial

Deep Brain Stimulation of the Dentate Nucleus for Motor Rehabilitation After Stroke

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if deep brain stimulation of the dentate nucleus (DN-DBS) works to promote chronic post-stroke upper limb motor function in adults. It will also learn about the safety of DN-DBS. The main questions it aims to answer are: Does DN-DBS paired with rehabilitation improve the upper limb motor function of participants more than rehabilitation only? What medical problems do participants have when using DN-DBS for post-stroke rehabilitation? Researchers will compare real DN-DBS+rehabilitation to sham DN-DBS+rehabilitation (electrodes will be implanted, but no electrical current is given) to see if DN-DBS works to promote chronic post-stroke upper limb motor function. Participants will: Undergo unilateral DN-DBS surgery Take real DN-DBS+rehabilitation or sham DN-DBS+rehabilitation as treatment for 6 months Visit the clinic every month during the DN-DBS+rehabilitation (treatment) period for programing, checkups and tests Visit the clinic at Day 1, 30, 90 and 365 after treatment period for checkups and tests
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-05; most recent amendment 2024-07-17.
Trial Details
NCT Number NCT06498934
Lead Sponsor Beijing Municipal Administration of Hospitals
Collaborators: Beijing Pins Medical Co., Ltd
Conditions Stroke, Upper Extremity Paresis
Enrollment 52 participants
Start Date 2024-09-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-07-18