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

NCT07543094 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543094 on ClinicalTrials.gov