Trials / Not Yet Recruiting
Not Yet RecruitingNCT06498934
Deep Brain Stimulation of the Dentate Nucleus for Motor Rehabilitation After Stroke
Deep Brain Stimulation of Cerebellar Dentate Nucleus Promotes Upper Limb Motor Function Recovery After Ischemic Stroke: a Randomized, Double-blind, Sham-controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- Sponsor
- Beijing Municipal Administration of Hospitals · Other Government
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-09-01
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
- First posted
- 2024-07-12
- Last updated
- 2024-07-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06498934. Inclusion in this directory is not an endorsement.