NCT07712159
Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder
레지스트리 요약
- 진행 상태
- 모집 전 (NOT_YET_RECRUITING)
- 질환/조건
- Major Depressive Disorder (MDD)
- 시험 유형
- 중재 연구 (INTERVENTIONAL)
- 단계
- 해당 없음(NA)
- 목적
- 치료
- 중재 유형
- 의료기기
- 개입·치료
- Temporal Interference transcranial Alternating Current Stimulation (TI-tACS), Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)
- Lead Sponsor
- Central South University (기타)
캐시 시각: 2026-09-10 23:27:11
요약
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.
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.
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