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NOT YET RECRUITING
NCT07712159
NA

Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder

Sponsor: Central South University

View on ClinicalTrials.gov

Summary

This multi-center, double-blind study, randomized controlled trial aims to evaluate the efficacy and safety of Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in patients with major depressive disorder (MDD) Participants with major depressive disorder will be randomized to receive high-frequency TI-tACS(130 Hz), low-frequency TI-tACS(2Hz), or sham stimulation targeting the right amygdala. The intervention consists of 20 stimulation sessions administered over 2 weeks (twice a day for 5 consecutive days, followed by a 2-day break, and another 5 consecutive days). Clinical assessments will be conducted at baseline, during treatment, and at multiple follow-up time points up to 6 months. The primary outcome for MDD is the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) at week 2. Secondary outcomes include changes in clinical symptoms, cognitive function, and safety profiles.

Official title: A Double-Blind, Randomized, Sham-Controlled Clinical Trial of Temporal Interference Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2026-10-10

Completion Date

2028-06

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DEVICE

Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)

Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a 130Hz envelope field in deep brain regions, particularly the right amygdala, through the interaction of two currents (2000 Hz, 2130Hz).

DEVICE

Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)

Sham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.

DEVICE

Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)

Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a 2Hz envelope field in deep brain regions, particularly the right amygdala, through the interaction of two currents (2000 Hz, 2002Hz).