Not Yet RecruitingNot Applicable

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

China52 participantsStarted 2024-09-01

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Within the first year to 3 years after the first stroke;
✓. Unilateral infarction located in the territory of the middle cerebral artery, but not involving the cerebellum, thalamus, and brainstem;
✓. Aged 18-80 years;
✓. TMS standard: TMS induces muscle evoked potential (MEP). In the contracted state of the paralyzed muscle (maximum voluntary contraction of 20-50%), a reliable standard MEP (in 5/10 trials with 50-100uv) can be induced;
✓. Researchers determine the medical and neurological condition of the participant to be stable based on the participant's medical history, physical examination, and neurological examination;
✓. Moderate-severe unilateral upper limb paralysis, i.e., the Fugl-Meyer Assessment (FMA-UE) scale score is ≤47;
✓. The distal extremity of the limb has some degree of motor function (flexion of the elbow joint or extension of the elbow joint or partial finger flexion with FMA-UE ≥1);
✓. mRS\<4 points, able to cooperate with assessment and rehabilitation;

Exclusion criteria

What they're measuring

Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change at Day 1

Timeframe: V6, One day after 6-months of therapy

Trial details

NCT IDNCT06498934

SponsorBeijing Municipal Administration of Hospitals

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Tao Xue, MD

86-18550213165 2992326676@qq.com

View on ClinicalTrials.gov More Stroke trials