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.
Age between 18 and 55 years (inclusive), any gender;
Diagnosis of a single or recurrent episode of Major Depressive Disorder (MDD) according to DSM-5 criteria, assessed by trained researchers using the Structured Clinical Interview for DSM-5 (SCID), without psychotic features;
HAMD-17 score ≥14; inadequate response despite regular and stable antidepressant treatment at an effective therapeutic dose for at least 6 weeks;
Education level: junior high school or above; adequate cognitive and language ability to understand and complete study assessments;
History of psychiatric disorders other than MDD;
Pregnancy or lactation;
Neurologic disorders or serious systemic diseases (e.g., thyroid disease, lupus erythematosus, diabetes, hepatic or renal impairment, active infection, major trauma);
History of significant head injury or coma
Parallel
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)
DeviceTemporal 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).
Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)
DeviceSham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)
DeviceTemporal 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).
Change from baseline in the Hamilton Depression Rating Scale(HAMD-17) scores at week 2.
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-administered instrument used to assess the severity of depressive symptoms. The scale consists of 17 items with a total score ranging from 0 to 52. Higher scores indicate more severe depressive symptoms. The primary outcome for MDD participants will be calculated as the change in HAMD-17 score from baseline to Week 2.
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered instrument used to assess the severity of depressive symptoms and sensitivity to treatment-related changes. The scale consists of 10 items with a total score ranging from 0 to 60. Higher scores indicate more severe depressive symptoms. The outcome will be calculated as the change in Montgomery-Åsberg Depression Rating Scale scores from baseline to each post-baseline assessment time point.
Adverse Events Related to treatment
Incidence, type, and severity of adverse events related to the transcranial temporal interference stimulation, assessed using a standardized Neuromodulation Adverse Effects Questionnaire.
Change in Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report questionnaire used to assess depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating greater depression severity. The outcome will be calculated as the change in PHQ-9 score from baseline to each post-baseline assessment time point.
Change in the Hamilton Anxiety Rating Scale (HAMA) Score
Anxiety symptom severity will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-administered scale with a total score range of 0 to 56. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. The outcome will be calculated as the change in HAMA total score from baseline to each post-baseline assessment time point.
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Central South University
Lead sponsor
Second Xiangya Hospital of Central South University
Collaborator
Neuropsychiatric Institute of Fuzhou Second General Hospital
Collaborator
Affiliated Wuhan Mental Health Center of Huazhong University of Science and Technology
Collaborator
Affiliated WuTaiShan Hospital of Medical College of Yangzhou University
Collaborator
Xianyue Psychiatric Hospital, Xiamen
Collaborator
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