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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Sponsor: Xuanwu Hospital, Beijing
Summary
This study aims to test whether transcranial temporal interference stimulation (tTIs) can improve upper limb motor function in patients in the early subacute stage after acute ischemic stroke. Participants will be randomly assigned to receive either active tTIs treatment or sham stimulation. All subjects will receive routine rehabilitation. The treatment will be given once daily for 20 consecutive days. Researchers will assess upper limb motor function before treatment, during the intervention and after the treatment course to compare the effect between the two groups. Safety will also be monitored throughout the study.
Official title: Effects of Transcranial Temporal Interference Stimulation on Upper-Limb Motor Recovery in Early Subacute Ischemic Stroke: A Randomized, Double-Blind, Sham-Controlled Pilot Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-11
Completion Date
2028-02
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Transcranial Temporal Interference Stimulation (tTIs)
Individualized active stimulation will be administered via the NervioX-1000 temporal interference stimulation system. The cerebellar dentate nucleus contralateral to the cerebral lesion is targeted using an electrode montage and current ratio optimized based on each participant's structural magnetic resonance imaging and finite-element electric field modeling. Stimulation parameters are kept constant throughout the intervention. Each session lasts 20 minutes, including 30-second ramp-up and ramp-down periods, with treatment administered once daily for 20 consecutive days.
Sham Transcranial Temporal Interference Stimulation (Sham tTIs)
Sham stimulation will be delivered using the same device, individualized electrode montage, positioning procedures, and session schedule as active stimulation. The device will reproduce the initial ramp-up and brief stimulation sensations and will then ramp down without delivering sustained active stimulation. A brief terminal ramp will reproduce end-of-session sensations. Each sham session lasts 20 minutes, including 30-second ramp-up and ramp-down periods, administered once daily for 20 consecutive days.
Locations (1)
Xuanwu Hospital, Capital Medical University
Beijing, China