NCT07912450

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

StatusEnrolling by Invitation

PhaseNot applicable

SponsorThe First Affiliated Hospital of Bengbu Medical University

Primary completionDec 2028 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 28, 2026 Study First Submitted

Endpoints

Primary

Proportion of subjects with modified Rankin Scale (mRS) score of 0-2 at 90 days

Timeframe: 90 days (± 4 days) after randomization

Secondary (1)

Distribution of modified Rankin Scale (mRS) scores at 90 days after randomization

Arms and interventions

Active Stimulation GroupExperimental

Intervention Group (Active Stimulation Group): After MRI-guided localization, participants will wear a non-invasive multi-channel electrode cap, typically with 16 channels. Focused stimulation of deep brain targets is achieved through current interference between multiple electrode pairs. The intervention will be administered once daily for 30 minutes per session, with 10 consecutive days as one treatment course.

Sham Stimulation GroupSham comparator

Participants will use the identical device and electrode cap. The stimulator will apply a weak current only during the initial 30 seconds and the final 30 seconds of each session to mimic the cutaneous sensations of active stimulation. No effective current will be delivered during the remainder of the session.

Devices: Transcranial Temporal Interference Stimulation (tTIS), Sham tTIS

Sites

1 site in 1 country

First Affiliated Hospital of Bengbu Medical UniversityBengbu, Anhui, China

About this trial

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.

Trial details

Enrollment: 378 participants (estimated)
Started: Mar 24, 2026
Study completion: Dec 2028 (estimated)
Eligibility: 18 to 80, all sexes, no healthy volunteers
Design: Interventional, randomized, triple blind, treatment
Oversight: Data monitoring committee
Conditions: Acute Ichemic Stroke
First posted: Nov 3, 2026
Registry updated: Nov 3, 2026
Last verified: Oct 2026

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