NCT07712159

Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder

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Registry fields

Overall status
NOT_YET_RECRUITING
Conditions
Major Depressive Disorder (MDD)
Study type
INTERVENTIONAL
Phase
NA
Primary purpose
TREATMENT
Intervention type
DEVICE
Interventions
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS), Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)
Lead sponsor
Central South University (OTHER)

Cached at: 2026-09-10 23:27:11

View on ClinicalTrials.gov

Brief 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.

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