Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment

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.

Conditions

• Amnestic Mild Cognitive Impairment - aMCI
• AD-MCI
• AD - Alzheimer's Disease
• FTD

Interventions

DEVICE

Temporal Interference Stimulation

Temporal interference stimulation will be delivered using two high-frequency alternating currents at 2000 Hz and 2100 Hz, generating a low-frequency envelope. Stimulation will be delivered in a theta-burst-like pattern with 2 seconds on and 8 seconds off. Frontal and temporal targets will be stimulated sequentially. In the sham-controlled group, participants will receive active stimulation during Days 6-10 following 5 days of sham stimulation. In the active stimulation groups, participants will receive active stimulation throughout the entire 10-day intervention period. Two sessions will be administered per day, with each session lasting 40 minutes.

DEVICE

Sham Temporal Interference Stimulation

Sham stimulation will use two identical high-frequency currents of 2000 Hz and 2000 Hz, producing no frequency difference and no modulation envelope. The stimulation timing, electrode placement, and procedures will be consistent with active stimulation to maintain blinding. In the sham-controlled group, sham stimulation will be administered during Days 1-5 before switching to active stimulation.

BEHAVIORAL

Targeted Cognitive Training

Participants will complete structured cognitive training tasks designed to engage specific cognitive processes associated with the study objectives.

BEHAVIORAL

General Cognitive Training

Participants will complete general cognitive training tasks involving multiple cognitive domains without specifically emphasizing the primary targeted cognitive process.

Sponsors & Collaborators

• Tianjin University

  collaborator OTHER

• Tianjin Huanhu Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-06-30

Completion

2029-06-30

Countries

• China

Study Locations