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NOT YET RECRUITING
NCT06498934
NA

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

Sponsor: Beijing Municipal Administration of Hospitals

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

Official title: Deep Brain Stimulation of Cerebellar Dentate Nucleus Promotes Upper Limb Motor Function Recovery After Ischemic Stroke: a Randomized, Double-blind, Sham-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2024-09-01

Completion Date

2027-12-31

Last Updated

2024-07-18

Healthy Volunteers

No

Interventions

DEVICE

deep brain stimulation

Stimulation of the dentate nucleus that is paired with upper limb rehabilitation movements.

OTHER

Rehabilitation

Rehabilitation movements to improve upper limb function after stroke

Locations (1)

Beijing Tiantan Hospital

Beijing, China