Generalized Anxiety Disorder (GAD)TIs-GADNCT07909200
Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder
A study testing Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in people with Generalized Anxiety Disorder (GAD), run by Central South University at 4 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- What is being tested?
- Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 4 sitesChina
- Study dates
- 25 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- 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;
- 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;
- 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);
- Suspected or confirmed history of alcohol or substance dependence;
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- Current severe suicidal ideation or recent suicide attempt;
- Current participation in another clinical trial or recent use of prohibited psychotropic medications;
- Positive urine drug screening or abnormal thyroid function tests;
- Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG);
- Inability to provide fully informed consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xueting Li, PhD Candidate contact
China4 sites
Brain Hospital of Hunan Province (Hunan Second People's Hospital)
Changsha, Hunan
Wenwen Ou, 86+15116200923, TIassistant701@163.com
Second Xiangya Hospital of Central South University
Changsha, Hunan
Hui Liang, 86+13876220412, 1136293417@qq.com
Neuropsychiatric Prevention and Treatment Hospital of Fuzhou Second General Hospital
Fuzhou, Fujian
Xueting Li, 86+13956590989, 2458261900@qq.com
Jiangsu Yangzhou Wutaishan Hospital
Yangzhou, Jiangsu
Jinrong Sun, 86+13813176637, 1723487395@qq.com
About this study
Official title: Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder: A Randomized Controlled Trial
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.
Read the detailed description
Generalized anxiety disorder (GAD) is characterized by persistent and excessive anxiety and worry. Intolerance of uncertainty is an important cognitive feature associated with pathological worry. The amygdala and bed nucleus of the stria terminalis (BNST) contribute to threat processing, with evidence suggesting differences in their responses to brief and sustained threats. Comparing interventions targeting these regions may help clarify their contributions to anxiety symptoms, intolerance of uncertainty, and persistent worry.
Temporal interference stimulation uses two kilohertz-frequency alternating currents with a small frequency difference to generate an amplitude-modulated electric field envelope at the difference frequency. This study will compare right BNST-targeted and right amygdala-targeted stimulation using a 5-Hz envelope, with sham stimulation as the control.
Individualized head models will be constructed from each participant's T1-weighted magnetic resonance images. Electric field modeling will guide scalp electrode placement for the assigned target. Stimulation intensity will be individually adjusted according to participant tolerability within a range of 1.5-3.5 mA per channel, expressed as zero-to-peak amplitude.
Electroencephalography and magnetic resonance imaging will be used to investigate changes in theta-band activity and functional connectivity within anxiety-related networks. Associations between these changes and improvements in clinical symptoms and cognitive measures will be examined to explore the neural mechanisms of stimulation at the two targets. Peripheral blood samples will be collected at baseline, Week 1, and Week 8 and stored for future exploratory biomarker analyses related to GAD and treatment response.
- Conditions
- Generalized Anxiety Disorder (GAD)
- Being tested
- Temporal Interference transcranial Alternating Current Stimulation (TI-tACS), Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)
- Keywords
- Generalized Anxiety Disorder, Temporal Interference Stimulation, Bed Nucleus of the Stria Terminalis, Intolerance of Uncertainty, Randomized Controlled Trial, Neuromodulation, quadruple-blind, Temporal Interference Transcranial Alternating Current Stimulation
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)Device
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)Device
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)Device
Sham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.
| Study group | Role | What they receive |
|---|---|---|
| Right BNST-targeted TI-tACS | Experimental | 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. Receives: Device: Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) |
| Right Amygdala-targeted TI-tACS | Experimental | 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. Receives: Device: Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) |
| Sham TI-tACS | Sham comparator | 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. Receives: Device: Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 1
Anxiety severity will be evaluated using the Hamilton Anxiety Rating Scale (HAMA), a clinician-administered instrument comprising 14 items. Total scores range from 0 to 56, with higher scores indicating more severe anxiety symptoms. The outcome is the change in HAMA total score from baseline to Week 1.
Measured: Baseline and Week 1
Secondary outcomes (8)
Clinical Response Rate
Clinical response 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. Clinical response is defined as a reduction of at least 50% in HAMA total score compared with baseline.
Measured: Week 1, Week 4, and Week 8
Clinical Remission Rate
Clinical remission 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. Clinical remission is defined as a HAMA total score of 7 or less at the corresponding assessment time point.
Measured: Week 1, Week 4, and Week 8
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
Anxiety severity will be evaluated using the Hamilton Anxiety Rating Scale (HAMA), a clinician-administered instrument comprising 14 items. Total scores range from 0 to 56, with higher scores indicating more severe anxiety symptoms. The outcome is the change in HAMA total score from baseline to each subsequent assessment time point.
Measured: Baseline, Week 1, Week 4, and Week 8
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17), a clinician-administered scale with a total score range of 0 to 52. Higher scores indicate greater depressive symptom severity, which represents a worse outcome. The outcome will be calculated as the change in HAMD-17 total score from baseline to each post-baseline assessment time point.
Measured: Baseline, Week 1, Week 4, and Week 8
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire with a total score range of 0 to 21. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. The outcome will be calculated as the change in GAD-7 score from baseline to each post-baseline assessment time point.
Measured: Baseline, Week 1, Week 4, and Week 8
Change in Intolerance of Uncertainty Scale (IUS) Score
Intolerance of uncertainty will be assessed using the Intolerance of Uncertainty Scale (IUS), a 27-item self-report questionnaire with a total score range of 27 to 135. Higher scores indicate greater intolerance of uncertainty, which represents a worse outcome. The outcome will be calculated as the change in IUS total score from baseline to each post-baseline assessment time point.
Measured: Baseline, Week 1, Week 4, and Week 8
Change in Anxiety and Depression Visual Analogue Scale Scores
Subjective anxiety and depression severity will be assessed using visual analogue scale ratings for anxiety and depression. Each visual analogue scale score ranges from 0 to 10, with higher scores indicating greater subjective symptom severity, which represents a worse outcome. The outcome will be calculated as the change in visual analogue scale scores from baseline to each post-baseline assessment time point
Measured: Baseline, Day 1, Week 1, Week 4, and Week 8
Treatment-Emergent Side Effects During the Intervention and Follow-up Period
Treatment-emergent side effects will be assessed using a physical treatment side-effect assessment that records the presence, type, severity, and relationship to the study intervention of adverse events. This outcome will be summarized as the occurrence and severity of treatment-emergent side effects during the intervention and follow-up period; higher severity indicates a worse safety outcome.
Measured: Week 1, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start25 Oct 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to three parallel groups: right BNST-targeted 5-Hz temporal interference stimulation, right amygdala-targeted 5-Hz temporal interference stimulation, or sham stimulation. Each participant will receive three 20-minute sessions per day, separated by 1-hour intervals, for 7 consecutive days (21 sessions in total).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated WuTaiShan Hospital of Medical College of Yangzhou University, Neuropsychiatric Institute of Fuzhou Second General Hospital, Brain Hospital of Hunan Province (Hunan Second People's Hospital), Second Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Yumeng Ju, Central South University
- Investigators
- Yumeng Ju, PhD, Principal investigator, Second Xiangya Hospital of Central South UniversityYan Zhang, PhD, Study chair, Second Xiangya Hospital of Central South UniversityJiawu Ji, PhD, Study director, Neuropsychiatric Prevention and Treatment Hospital of Fuzhou Second General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909200
- Sponsor's protocol ID
- FZLL202651
- Acronym
- TIs-GAD
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset includes sensitive neuroimaging and biological data that may compromise participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07909200
- Acronym / sponsor ID
- TIs-GAD / FZLL202651
- Conditions
- Generalized Anxiety Disorder (GAD)
- Keywords
- Generalized Anxiety Disorder, Temporal Interference Stimulation, Bed Nucleus of the Stria Terminalis, Intolerance of Uncertainty, Randomized Controlled Trial, Neuromodulation, quadruple-blind, Temporal Interference Transcranial Alternating Current Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Affiliated WuTaiShan Hospital of Medical College of Yangzhou University, Neuropsychiatric Institute of Fuzhou Second General Hospital, Brain Hospital of Hunan Province (Hunan Second People's Hospital), Second Xiangya Hospital of Central South University
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Generalized anxiety disorder (GAD) is characterized by persistent and excessive anxiety and worry. Intolerance of uncertainty is an important cognitive feature associated with pathological worry. The amygdala and bed nucleus of the stria terminalis (BNST) contribute to threat processing, with evidence suggesting differences in their responses to brief and sustained threats. Comparing interventions targeting these regions may help clarify their contributions to anxiety symptoms, intolerance of uncertainty, and persistent worry.
Temporal interference stimulation uses two kilohertz-frequency alternating currents with a small frequency difference to generate an amplitude-modulated electric field envelope at the difference frequency. This study will compare right BNST-targeted and right amygdala-targeted stimulation using a 5-Hz envelope, with sham stimulation as the control.
Individualized head models will be constructed from each participant's T1-weighted magnetic resonance images. Electric field modeling will guide scalp electrode placement for the assigned target. Stimulation intensity will be individually adjusted according to participant tolerability within a range of 1.5-3.5 mA per channel, expressed as zero-to-peak amplitude.
Electroencephalography and magnetic resonance imaging will be used to investigate changes in theta-band activity and functional connectivity within anxiety-related networks. Associations between these changes and improvements in clinical symptoms and cognitive measures will be examined to explore the neural mechanisms of stimulation at the two targets. Peripheral blood samples will be collected at baseline, Week 1, and Week 8 and stored for future exploratory biomarker analyses related to GAD and treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to three parallel groups: right BNST-targeted 5-Hz temporal interference stimulation, right amygdala-targeted 5-Hz temporal interference stimulation, or sham stimulation. Each participant will receive three 20-minute sessions per day, separated by 1-hour intervals, for 7 consecutive days (21 sessions in total).
| Arm | Type | Receives |
|---|---|---|
| Right BNST-targeted TI-tACS | Experimental | Device: Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)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. |
| Right Amygdala-targeted TI-tACS | Experimental | Device: Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)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. |
| Sham TI-tACS | Sham comparator | Device: Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
- 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;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Right BNST-targeted TI-tACS |
| 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 | Right Amygdala-targeted TI-tACS |
| 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. | Device | Sham TI-tACS |
Primary outcome
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 1
Time frame: Baseline and Week 1
Anxiety severity will be evaluated using the Hamilton Anxiety Rating Scale (HAMA), a clinician-administered instrument comprising 14 items. Total scores range from 0 to 56, with higher scores indicating more severe anxiety symptoms. The outcome is the change in HAMA total score from baseline to Week 1.
8 secondary outcomes
Clinical Response Rate
Time frame: Week 1, Week 4, and Week 8
Clinical Remission Rate
Time frame: Week 1, Week 4, and Week 8
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
Time frame: Baseline, Week 1, Week 4, and Week 8
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
Time frame: Baseline, Week 1, Week 4, and Week 8
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline, Week 1, Week 4, and Week 8
Change in Intolerance of Uncertainty Scale (IUS) Score
Time frame: Baseline, Week 1, Week 4, and Week 8
Change in Anxiety and Depression Visual Analogue Scale Scores
Time frame: Baseline, Day 1, Week 1, Week 4, and Week 8
Treatment-Emergent Side Effects During the Intervention and Follow-up Period
Time frame: Week 1, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset includes sensitive neuroimaging and biological data that may compromise participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xueting Li, PhD Candidate contact
Yumeng Ju, PhD principal investigator
Second Xiangya Hospital of Central South University
Yan Zhang, PhD study chair
Second Xiangya Hospital of Central South University
Jiawu Ji, PhD study director
Neuropsychiatric Prevention and Treatment Hospital of Fuzhou Second General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in people with Generalized Anxiety Disorder (GAD), run by Central South University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yumeng Ju, PhD (86+18100731091, yumeng.ju@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 1 (time frame: Baseline and Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026; AzTrials last refreshed its copy on 2 Nov 2026.