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ENROLLING BY INVITATION
NCT07543094
NA

Efficacy and Safety of Temporal Interference Stimulation on Cognitive Function in Patients With Early-Stage Alzheimer's Disease

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

This study aims to investigate the efficacy and safety of a novel non-invasive brain stimulation technique-Temporal Interference Stimulation (TIS)-in patients with early-stage Alzheimer's disease. A total of 40 participants will be randomly assigned to either the TIS group or the sham stimulation group. The intervention will last for 2 weeks, with cognitive and safety assessments at baseline, post-treatment, and 12 weeks after treatment.

Official title: A Randomized, Double-Blind, Controlled Trial to Evaluate the Efficacy and Safety of Temporal Interference Stimulation on Cognitive Function in Patients With Early-Stage Alzheimer's Disease

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-11-01

Completion Date

2027-09-30

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

DEVICE

Temporal Interference Stimulation

Device: The non-invasive brain stimulator NervioX is used to administer Temporal Interference Stimulation (TIS). Stimulation Parameters: Frequencies: 2000 Hz and 2005 Hz (resulting in a 5 Hz theta rhythm envelope). Stimulation Intensity: 1.0-2.0 mA (peak current). Stimulation Target: Bilateral hippocampus Session Duration: 40 minutes per session. Treatment Course: 5 sessions per week, for 2 consecutive weeks, totaling 10 sessions.

DEVICE

Sham Stimulation

Device: The same NervioX device is used. Stimulation Parameters: The device is programmed to deliver a real stimulation (1.0-2.0 mA) for the initial 30 seconds of the session to mimic the initial sensation experienced by the active group. Subsequently, the current is automatically reduced to 0 mA for the remainder of the 40-minute session. The device screen continues to display the stimulation as ongoing to maintain the blinding. The session frequency and total course (5 sessions/week for 2 weeks, 10 sessions total) are identical to the active intervention group.

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China