Clinical Trial

Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment

Study acronym: TIS
Recruiting
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Summary
This study aims to evaluate the efficacy and safety of temporal interference stimulation (TIS), a non-invasive neuromodulation technique, in improving cognitive function in patients with cognitive impairment. TIS uses two high-frequency currents applied transcranially, which intersect within the brain to generate a low-frequency modulation field. This technique selectively modulates deep brain regions while minimizing the stimulation of superficial cortical layers. Participants will undergo individualized MRI-based modeling to determine the optimal electrode placement and stimulation parameters. The intervention consists of 10 stimulation sessions over a period of 14 days, using either active TIS or sham stimulation. Cognitive assessments, EEG recordings, and functional MRI scans will be conducted at baseline; 5 days after intervention initiation; at the end of the 10-day intervention; and during follow-up assessments at 4 weeks, 8 weeks, and 12 weeks post-intervention to evaluate both immediate and long-term effects on cognitive performance and neural activity. The study aims to determine whether TIS can serve as a feasible and effective neuromodulation strategy for individuals with cognitive impairment.
Trial Details
NCT Number NCT07643363
Lead Sponsor Tianjin Huanhu Hospital
Collaborators: Tianjin University
Conditions Amnestic Mild Cognitive Impairment - aMCI, AD-MCI, AD - Alzheimer's Disease, FTD
Enrollment 60 participants
Start Date 2026-07-01
Primary Completion 2028-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-11