Deep Brain Stimulation of the Dentate Nucleus for Motor Rehabilitation After Stroke
NCT Number: NCT06498934
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Upper Extremity Paresis
Interventions: DEVICE: deep brain stimulation|OTHER: Rehabilitation
Sponsor: Beijing Municipal Administration of Hospitals
Collaborators: Beijing Pins Medical Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-12-31
Locations: Beijing Tiantan Hospital, Beijing, 100070, China

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

Primary Outcome Measures: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change at Day 1, The Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for difference in average change at Day-1 after 6-months of therapy compared to baseline (Difference in average change in FMA-UE from baseline \[V0\] to one day after therapy \[V6\]). FMA-UE was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment)., V6, One day after 6-months of therapy
Secondary Outcome Measures: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change at Day 90, The Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for difference in average change at Day-90 after 6-months of therapy compared to baseline (Difference in average change in FMA-UE from baseline \[V0\] to 90 days after therapy \[V8\]). FMA-UE was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment)., V8, 90 days after 6-months of therapy|Wolf Motor Function Test (WMFT) Average Change at Day 1, The Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal). WMFT Day 1 - is a measure of the functional assessment change from baseline to one day after 6-months of therapy., V6, One day after 6-months of therapy|Wolf Motor Function Test (WMFT) Average Change at Day 90, The Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal). WMFT Day 90 - is a measure of the functional assessment change from baseline to 90 days after 6-months of therapy., V8, 90 days after 6-months of therapy|Action Research Arm Test (ARAT) Average Change at Day 1, Action Research Arm Test (ARAT) is a common scale of fine movements of distal upper limbs after stroke. The functional assessment range is an average of 19 sub-items with a range from 0 to 3, with 0 (meaning did not attempt) to 5 (meaning normal). ARAT Day 1 - is a measure of the functional assessment change from baseline to one day after 6-months of therapy., V6, One day after 6-months of therapy|Action Research Arm Test (ARAT) Average Change at Day 90, Action Research Arm Test (ARAT) is a common scale of fine movements of distal upper limbs after stroke. The functional assessment range is an average of 19 sub-items with a range from 0 to 3, with 0 (meaning did not attempt) to 5 (meaning normal). ARAT Day 90 - is a measure of the functional assessment change from baseline to 90 days after 6-months of therapy., V8, 90 days after 6-months of therapy