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Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder
Sponsor: Central South University
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
Conditions
Interventions
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).
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)
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