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Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
Enrollment reduced 47% 192 → 102 participants
See other at-risk trials from Central South University

Record History

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  1. Start date pushed from Sep 15, 2026 to Oct 10, 2026 Show 5 more changesShow less
    • Interventions modified
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: 15 to 21
    • Collaborators: 6 to 5
    • Study description expanded, about 1 word
  2. Primary endpoint(s) modifiedv2 Show 7 more changesShow less
    • Enrollment reduced: 192 → 102 participants
    • Start date: Jun 2026 to Sep 15, 2026
    • Trial arms changed: 6 → 3
    • Eligibility criteria shortened, about 24 words
    • Secondary endpoints: 17 to 15
    • Study description shortened, about 25 words
    • Study title shortened, about 4 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07712159
Lead Sponsor Central South University
Collaborators: Second Xiangya Hospital of Central South University, Neuropsychiatric Institute of Fuzhou Second General Hospital, Affiliated Wuhan Mental Health Center of Huazhong University of Science and Technology, Affiliated WuTaiShan Hospital of Medical College of Yangzhou University, Xianyue Psychiatric Hospital, Xiamen
Conditions
(from sponsor)		 Major Depressive Disorder (MDD)
Related terms Major Depressive Disorder
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov