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

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcranial Temporal Interference Stimulation (tTIS): Transcranial temporal interference stimulation (tTIS) is delivered via a non-invasive multi-channel electrode cap (typically 16 channels). MRI-guided target localization is used to achieve focused deep brain stimulation through multi-electrode current interference. For the active stimulation condition, the intervention is administered once daily for 30 minutes per session, for a total of 10 days (one treatment course). For the sham condition, the identical device and cap are used, but the stimulator is turned on briefly (for 30 seconds at the start and end) to mimic cutaneous sensations, with no effective current output during the remainder of the session.

Sham tTIS: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Proportion of subjects with modified Rankin Scale (mRS) score of 0-2 at 90 days — 90 days (± 4 days) after randomization
  To evaluate the neurological recovery of subjects at 90 days after randomization. The modified Rankin Scale (mRS) will be used for assessment. The mRS score ranges from 0 to 6, where 0 indicates no symptoms, 1 indicates no significant disability, and 2 indicates slight disability but able to look after own affairs without assistance. This outcome measure defines an mRS score of 0-2 as a good functional outcome (functional independence), and the proportion of subjects achieving an mRS score of 0-2 will be calculated.

Trial sites (1)

More The First Affiliated Hospital of Bengbu Medical University trials in China

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