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NOT YET RECRUITING
NCT07909200
NA

Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder

Sponsor: Central South University

View on ClinicalTrials.gov

Summary

This randomized controlled trial will use a three-arm, parallel-group design to evaluate the efficacy and safety of 5-Hz Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in adults with generalized anxiety disorder (GAD). A total of 75 participants will be randomized in a 1:1:1 ratio to receive stimulation targeting the right bed nucleus of the stria terminalis (BNST), stimulation targeting the right amygdala, or sham stimulation. Participants will receive three 20-minute sessions per day, with 1-hour intervals between sessions, for 7 consecutive days (21 sessions in total). The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA) total score from baseline to Week 1. Secondary and exploratory assessments will include clinical symptoms, intolerance of uncertainty and related cognitive characteristics, treatment tolerability, adverse events, and EEG and MRI measures. Follow-up assessments will be conducted at Week 1, Week 4, and Week 8 from baseline to assess the durability of clinical effects and safety.

Official title: Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-10-25

Completion Date

2027-06-30

Last Updated

2026-11-02

Healthy Volunteers

No

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 an envelope field (particularly 5 Hz) in deep brain regions, particularly the right BNST, through the interaction of two currents (2000 Hz, 2005Hz).

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 an envelope field (particularly 5 Hz) in deep brain regions, particularly the right Amygdala, through the interaction of two currents (2000 Hz, 2005Hz)

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.

Locations (4)

Neuropsychiatric Prevention and Treatment Hospital of Fuzhou Second General Hospital

Fuzhou, Fujian, China

Brain Hospital of Hunan Province (Hunan Second People's Hospital)

Changsha, Hunan, China

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Yangzhou Wutaishan Hospital

Yangzhou, Jiangsu, China