NCT07903116Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Clinical Application Study of Closed-Loop Spinal Cord Stimulation Brain-Computer Interface System for Motor Function Reconstruction in Post-Stroke Limb Hemiplegia
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
This study evaluates a new closed-loop rehabilitation system for stroke survivors with arm weakness. The system combines a brain-computer interface (BCI, a special cap that reads brain signals), spinal cord stimulation (a temporary implanted electrode that sends gentle electrical pulses to the spine), and a robotic hand exoskeleton. When the participant imagines moving their affected hand, the system detects this intention from brain signals and immediately triggers the spinal stimulation and robotic assistance to help complete the movement. The goal is to test whether this "brain-spine-hand" closed-loop approach is safe and can improve upper limb function after stroke. About 30 stroke patients with chronic arm weakness will be enrolled. Participants will first undergo brain signal testing to confirm they can produce detectable movement intentions. Eligible participants will then have a temporary spinal cord stimulator electrode placed under the skin near the spine. Over the next 4 weeks, they will receive daily training sessions (about 90 minutes, 5 days per week) using the closed-loop system. After 4 weeks, the electrode will be removed, and participants will continue standard rehabilitation. Hand and arm function will be assessed before, during, and after the intervention.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Oct 2026
- Start date
- Sept 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Stroke
- NCT number
- NCT07903116
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Sept 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cervical/thoracic spine surgery, severe spinal deformity, or severe spinal stenosis precluding SCS electrode placement.
- Implanted electronic devices (e.g., cochlear implant, pacemaker/ICD, drug pump).
Other illness
- Active infection, fever, or unstable vital signs/intracranial condition.
- Severe sports injury or surgical history of affected limb (e.g., muscle tear, tendon rupture, rhabdomyolysis).
- Severe comorbidities (e.g., epilepsy, malignancy, severe cerebrovascular disease/brain tumor, uncontrolled or grade 3 hypertension, diabetes, heart disease, hepatic/renal insufficiency, electrolyte imbalance, coagulopathy, autoimmune disease, long-term use of drugs suppressing neuronal activity).
- Confirmed psychiatric disorders (e.g., depression, anxiety, OCD, schizophrenia, autism, chronic sleep disorder, consciousness disorder).
- Other conditions deemed unsuitable by surgeon/investigator.
Other
- Need for MRI during device implantation period.
- Hypotonic or flaccid paralysis of affected limb.
- Other causes of motor dysfunction (e.g., ALS, myasthenia gravis, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis).
- Severe pain or musculoskeletal deformity affecting training.
- Pregnancy, breastfeeding, or planning pregnancy within 3 months.
- Participated in other clinical trials within past month or currently participating.
- Poor compliance of participant, family, or caregiver.
Who the study is looking for
- Age 18-60 years.
- Unilateral upper limb motor dysfunction due to primary stroke.
- Stable brain lesion and underlying etiology.
- Upper limb motor dysfunction for \>6 months with no recent improvement despite standardized rehabilitation (plateau phase).
- Detectable wrist/finger extension motor intention (pre-activation recordable by sEMG).
- Upper extremity Fugl-Meyer Assessment score 10-42 (moderate to severe).
- Affected major muscle strength ≥ grade 1.
- Normal hearing and language comprehension; able to cooperate with training.
- Mini-Mental State Examination (MMSE) score ≥ 22.
- Signed informed consent.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.