An interventional study of Spinal Cord Stimulation and Non-invasive Brain-Computer Interface in Stroke, Motor Dysfunction and Brain-computer Interface, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Spinal Cord Stimulation · Device: Non-invasive Brain-Computer Interface · Device: Hand Exoskeleton · Behavioral: Motor Imagery Rehabilitation Training
Temporary invasive spinal cord stimulation triggered by motor intention to facilitate neural excitability.
Also known as: SCS
Non-invasive EEG-based system for real-time motor intention detection.
Robotic exoskeleton guiding affected hand to complete grasping movements, synchronized with decoded motor intention and SCS stimulation.
Closed-loop motor imagery training combining BCI, SCS, and exoskeleton feedback.
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.
Time frame: Baseline and 1 month
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.
Time frame: Week 4 of stimulation (electrode removal) and 1 month after electrode removal
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.
Time frame: Week 4 of stimulation (electrode removal) and 1 month after electrode removal
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.
Time frame: Week 4 of stimulation (electrode removal), 1 month and 2 months after electrode removal
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.
Time frame: Week 4 of stimulation (electrode removal), 1 month and 2 months after electrode removal
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.
Time frame: Week 4 of stimulation (electrode removal), 1 month and 2 months after electrode removal
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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