Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder and Generalized Anxiety Disorder

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) and generalized anxiety disorder (GAD).

All participants will be enrolled as two independent cohorts and randomized separately within each diagnostic group. 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. Participants with generalized anxiety disorder will be randomized to receive high-frequency TI-tACS(80Hz), low-frequency TI-tACS(5Hz), 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 the MDD cohort is the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) at week 2. The primary outcome for the GAD cohort is the change from baseline in the Hamilton Anxiety Rating Scale (HAMA) at week 2. Secondary outcomes include changes in clinical symptoms, cognitive function, and safety profiles in both the MDD and GAD cohorts.

Conditions

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)

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 low-frequency envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents. In the MDD cohort, low-frequency stimulation will be delivered at 2 Hz and high-frequency stimulation at 130 Hz. In the GAD cohort, low-frequency stimulation will be delivered at 5 Hz and high-frequency stimulation at 80 Hz.

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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• Neuropsychiatric Institute of Fuzhou Second General Hospital

  collaborator UNKNOWN

• Affiliated Wuhan Mental Health Center of Huazhong University of Science and Technology

  collaborator UNKNOWN

• Affiliated WuTaiShan Hospital of Medical College of Yangzhou University

  collaborator UNKNOWN

• Xianyue Psychiatric Hospital, Xiamen

  collaborator UNKNOWN

• Central South University

  lead OTHER

Principal Investigators

• Yumeng Ju, PhD · Second Xiangya Hospital of Central South University

• Yan Zhang, PhD · Second Xiangya Hospital of Central South University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-12-31

Completion

2028-06-30