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StrokeCL-SCS-BCINCT07903116

Closed-Loop SCS-BCI for Post-Stroke Hemiplegia

A study testing Spinal Cord Stimulation, Non-invasive Brain-Computer Interface and Hand Exoskeleton in people with Stroke and Motor Dysfunction, run by Beijing Tiantan Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Spinal Cord Stimulation, Non-invasive Brain-Computer Interface and Hand Exoskeleton
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Sep 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • Active infection, fever, or unstable vital signs/intracranial condition.
  • 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 sports injury or surgical history of affected limb (e.g., muscle tear, tendon rupture, rhabdomyolysis).
  • Severe pain or musculoskeletal deformity affecting training.
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  • Previous cervical/thoracic spine surgery, severe spinal deformity, or severe spinal stenosis precluding SCS electrode placement.
  • 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).
  • Implanted electronic devices (e.g., cochlear implant, pacemaker/ICD, drug pump).
  • 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.
  • Other conditions deemed unsuitable by surgeon/investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ran Huo contact

+861059976966

huoran@bjtth.org

China1 site

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100071

    Ran Huo, +861059976966

Other trials in China

About this study

Official title: Clinical Application Study of Closed-Loop Spinal Cord Stimulation Brain-Computer Interface System for Motor Function Reconstruction in Post-Stroke Limb Hemiplegia

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.

Being tested
Spinal Cord Stimulation, Non-invasive Brain-Computer Interface, Hand Exoskeleton, Motor Imagery Rehabilitation Training
Medical subject headings
Stroke, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal Cord StimulationDevice

    Also called SCS

    Temporary invasive spinal cord stimulation triggered by motor intention to facilitate neural excitability.

  • Non-invasive Brain-Computer InterfaceDevice

    Non-invasive EEG-based system for real-time motor intention detection.

  • Hand ExoskeletonDevice

    Robotic exoskeleton guiding affected hand to complete grasping movements, synchronized with decoded motor intention and SCS stimulation.

  • Motor Imagery Rehabilitation TrainingBehavioural

    Closed-loop motor imagery training combining BCI, SCS, and exoskeleton feedback.

Study groups in NCT07903116
Study groupRoleWhat they receive
Closed-loop SCS-BCI for Post-Stroke Upper Limb RehabilitationExperimentalNot described
Receives: Device: Spinal Cord Stimulation; Device: Non-invasive Brain-Computer Interface; Device: Hand Exoskeleton; Behavioral: Motor Imagery Rehabilitation Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score

    Change in upper limb motor function measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). The total score ranges from 0 to 66, with higher scores indicating better upper limb motor function. Change is calculated as the score at 1 month after electrode removal minus the baseline score.

    Measured: Baseline and 1 month

Secondary outcomes (5)

  1. Change in Action Research Arm Test Score

    Upper limb functional performance will be evaluated using the Action Research Arm Test (ARAT), which assesses grasp, grip, pinch, and gross arm movements. The total score ranges from 0 to 57, with higher scores indicating better upper limb function. Change will be calculated as the score at 1 month after electrode removal minus the score at Week 4 of stimulation.

    Measured: Week 4 of stimulation (electrode removal) and 1 month after electrode removal

  2. Change in Brunnstrom Recovery Stage of the Upper Extremity

    Motor recovery of the affected upper extremity will be assessed using the Brunnstrom Recovery Stages. Recovery is classified into six stages, ranging from Stage I (flaccidity without voluntary movement) to Stage VI (near-normal voluntary movement and coordination). Higher stages indicate better motor recovery. Change will be calculated as the stage at 1 month after electrode removal minus the stage at Week 4 of stimulation.

    Measured: Week 4 of stimulation (electrode removal) and 1 month after electrode removal

  3. Change in Nine-Hole Peg Test Completion Time

    Fine motor dexterity of the affected hand will be assessed using the Nine-Hole Peg Test (NHPT). The time required to place and remove nine pegs will be recorded in seconds. Shorter completion times indicate better fine motor performance. Change will be calculated as the completion time at each follow-up assessment minus the completion time at electrode removal.

    Measured: Week 4 of stimulation (electrode removal), 1 month and 2 months after electrode removal

  4. Change in Grip Strength of the Affected Hand

    Grip strength of the affected hand will be measured using a hand dynamometer and recorded in kilograms (kg). Higher values indicate greater grip strength. Change will be calculated as the grip strength at each follow-up assessment minus the grip strength at electrode removal.

    Measured: Week 4 of stimulation (electrode removal), 1 month and 2 months after electrode removal

  5. Change in Lateral Pinch Strength of the Affected Hand

    Lateral pinch strength of the affected hand will be measured using a pinch gauge and recorded in kilograms (kg). Lateral pinch strength represents the force generated between the thumb and the lateral aspect of the index finger. Higher values indicate greater pinch strength. Change will be calculated as the value at each follow-up assessment minus the value at electrode removal.

    Measured: Week 4 of stimulation (electrode removal), 1 month and 2 months after electrode removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07903116
Sponsor's protocol ID
KYXM202605085208002
Other IDs
NJJK-01
Acronym
CL-SCS-BCI
Status last verified
Oct 2026
First submitted
10 Oct 2026
Last updated
29 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulation, Non-invasive Brain-Computer Interface and Hand Exoskeleton in people with Stroke and Motor Dysfunction, run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ran Huo (+861059976966, huoran@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07903116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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