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

Key facts

Who runs it
Central South University
Where
China4 sites in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
75 people, planned
Started
25 Oct 2026
Expected to end
30 Jun 2027
Type of study
Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)
  • Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)
Record updated
2 November 2026

Who can take part

Age
18 years to 55 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Aged 18 to 55 years, inclusive, of any sex
  • Diagnosis of generalized anxiety disorder (GAD) according to DSM-5 criteria, assessed by trained researchers using the Structured Clinical Interview for DSM-5 (SCID), without psychotic features
  • Hamilton Anxiety Rating Scale (HAMA) total score of 14 or higher at screening
  • Has completed at least junior high school education and has sufficient hearing, reading, writing, and comprehension abilities to complete study assessments
  • Is willing and able to provide written informed consent and comply with study visits, treatment procedures, laboratory tests, and other study requirements

Who cannot take part

  • Participants with a current or previous diagnosis of a major psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), such as schizophrenia spectrum and other psychotic disorders or bipolar and related disorders
  • Received any standardized neuromodulation therapy targeting the nervous system within the past 6 months before enrollment, including but not limited to electroconvulsive therapy (ECT), deep brain stimulation (DBS), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS)
  • Current participation in another clinical trial or recent use of prohibited psychotropic medications
  • Positive urine drug screening or abnormal thyroid function tests
  • 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
  • Suspected or confirmed history of alcohol or substance dependence
  • Pregnancy or lactation
  • Current severe suicidal ideation or recent suicide attempt
  • Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG)
  • Inability to provide fully informed consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Right BNST-targeted TI-tACSTreatment being tested

    Participants will receive 5-Hz temporal interference stimulation targeting the right bed nucleus of the stria terminalis (BNST), for 20 minutes per session, three sessions per day with 1-hour intervals, for 7 consecutive days, for a total of 21 sessions.

    Treatment: Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)

  • Right Amygdala-targeted TI-tACSTreatment being tested

    Participants will receive 5-Hz temporal interference stimulation targeting the right amygdala, for 20 minutes per session, three sessions per day with 1-hour intervals, for 7 consecutive days, for a total of 21 sessions.

    Treatment: Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)

  • Sham TI-tACSSham treatment, for comparison

    Participants will receive sham temporal interference stimulation, for 20 minutes per session, three sessions per day with 1-hour intervals, for 7 consecutive days, for a total of 21 sessions.

    Treatment: Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder: A Randomized Controlled Trial
Fit questions
Built from NCT07909200, who can take part
Record updated
2 November 2026