Brain stimulation with an electrode cap for arm and leg movement after acute stroke
Tests a cap-based brain stimulation device in adults with recent ischemic stroke and movement problems.
Plain-language title generated from the registry record
Registry title: Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
Key facts
- Where
- Bengbu, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07912450, who can take part
Where in China
- First Affiliated Hospital of Bengbu Medical UniversityBengbu, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Bengbu Medical University
- Trial code
- NCT07912450
- Record updated
- 3 November 2026
- Original description
This trial enrolls patients with acute ischemic stroke. The key inclusion criteria are: patient age 18-80 years, within 72 hours of symptom onset, National Institutes of Health Stroke Scale (NIHSS) score of 4-24, motor dysfunction score of one upper and lower limb ≥ 4, and pre-stroke modified Rankin Scale (mRS) 0-2. Subjects will be randomized in a 1:1 ratio.Read full original descriptionShow less
Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
This trial enrolls patients with acute ischemic stroke. The key inclusion criteria are: patient age 18-80 years, within 72 hours of symptom onset, National Institutes of Health Stroke Scale (NIHSS) score of 4-24, motor dysfunction score of one upper and lower limb ≥ 4, and pre-stroke modified Rankin Scale (mRS) 0-2. Subjects will be randomized in a 1:1 ratio.
In addition to standard treatment, the intervention group (real stimulation group) will wear a non-invasive multi-channel electrode cap, typically using 16 channels, after MRI navigation and positioning. The device achieves focused stimulation of deep targets through current interference between multiple electrode pairs. This will be performed once daily for 30 minutes per session, with 10 days as one treatment course.
The control group (sham stimulation group) will use the same equipment and electrode cap. The stimulator will only apply weak current during the initial 30 seconds and the 30 seconds before the end to simulate the skin sensation of real stimulation, with no effective current output for the majority of the remaining time. This mode has been proven to effectively maintain the blinding of subjects and assessors.
Efficacy evaluation endpoints:
* Primary outcome: 90-day mRS score 0-2; * Secondary outcomes: 90-day mRS score distribution; 90-day mRS 0-1 or recovery to pre-stroke disability status (if pre-stroke mRS > 1); NIHSS score 10 days after treatment.
Inclusion: Acute ischemic stroke confirmed by CT or MRI; Age 18 to 80 years; Time from symptom onset ≤ 72 hours; Baseline NIHSS score 4-24, and pre-stroke mRS score 0-2; Motor dysfunction score of unilateral upper and lower limbs ≥ 4.
Exclusion: Hemorrhagic stroke or history of stroke with severe residual disability; 2. Presence of intracranial or cranial metal or electronic implants, cardiac pacemaker, or severe skull defect; 3. Skin injury/inflammation at the stimulation site; 4. History of epilepsy or high risk of inducing seizures during stimulation; 5. Systolic blood pressure > 170 mmHg and/or diastolic blood pressure > 100 mmHg; 6. Severe impairment of vital organs such as heart and lungs, and severe hepatic and renal insufficiency; 7. History of psychiatric disorders or inability to cooperate with treatment; 8. Any condition that, in the investigator's judgment, may pose a hazard to the patient or affect the patient's participation in the study if study treatment is initiated; 9. Participation in other interventional clinical trials within the past 3 months; 10. Pregnant or lactating women, or those unwilling to take effective contraceptive measures during the trial; -.