Health Trials

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

ConditionsStrokeUpper Extremity Paresis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Municipal Administration of Hospitals

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

Primary hemorrhagic stroke or severe hemorrhagic conversion;

Any progressive neurological or somatic disease that impairs the function of the affected limb other than stroke;

Moderate to severe neglect or disinhibition of the affected limb;

Any other neurological disorder that may compromise study safety, including central nervous system vasculitis, intracranial tumors, intracranial aneurysms, multiple sclerosis, or arteriovenous malformations;

Trial design

Treatments tested in this trial

  • deep brain stimulation
  • Rehabilitation

Treatment groups

52 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Municipal Administration of Hospitals

Lead sponsor

Beijing Tiantan Hospital

Sponsor institution

Beijing Pins Medical Co., Ltd

Collaborator

Source ClinicalTrials.gov