AnxietyNCT06699706
Neuroimage-guided Dual-target Continuous Theta Burst Stimulation for Generalized Anxiety Disorder
A study testing Continuous theta-burst stimulation in people with Anxiety and Transcranial Magnetic Stimulation Repetitive, run by Anhui Medical University at 1 site in China.
Trial summary
The aim of this clinical trial was to determine whether image-guided dual-target cTBS is effective for anxiety disorders. The main questions it aims to answer are: 1. Does dual-target cTBS improve patients' anxiety symptoms? 2. Does dual-target cTBS improve patients' somatization symptoms? 3. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety, Transcranial Magnetic Stimulation Repetitive
- What is being tested?
- Continuous theta-burst stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for anxiety
- HAMA score ≥ 14 (HAMD score < 17).
- Age range: 18-60 years.
- Right-handed.
- Able to cooperate with the collection of general demographic information and neuropsychological testing.
- Patients are either medication-free or maintain a consistent medication regimen during cTBS treatment.-
Who cannot join
- Presence of organic brain lesions detected on MRI.
- History of alcohol or drug dependence.
- Diagnosis of other neuropsychiatric disorders, such as epilepsy, autism, obsessive-compulsive disorder, or autoimmune encephalitis.
- Contraindications to MRI scanning.-
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this clinical trial was to determine whether image-guided dual-target cTBS is effective for anxiety disorders. The main questions it aims to answer are:
- Does dual-target cTBS improve patients' anxiety symptoms?
- Does dual-target cTBS improve patients' somatization symptoms?
- Researchers will compare cTBS real and sham stimulation to determine whether cTBS is effective in treating anxiety disorders.
Participants will:
- Received either cTBS treatment or sham stimulation for 7 consecutive days
- Psychological assessment and MRI scan were performed before treatment, within 2 days, 2 weeks and 1 month after treatment
- Adverse reactions during the experiment were recorded
Read the detailed description
This was a randomized, double-blind, sham-controlled clinical trial. Patients with generalized anxiety disorder (GAD) were recruited from the Neurology Outpatient Clinic and Psychiatry Outpatient Clinic at the First Affiliated Hospital of Anhui Medical University, as well as the Psychiatry Outpatient Clinic and Inpatient Ward at the Second Affiliated Hospital of Anhui Medical University. The diagnosis of GAD was based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), independently confirmed by two professional psychiatrists. Patients meeting the inclusion criteria provided written informed consent and were randomly assigned to either a true cTBS treatment group or a sham stimulation group.
Patients will be randomly assigned to receive either active or sham cTBS treatments according to a computer-generated list by an unblinded investigator not involved with study ratings/analysis. The assignment will be executed by utilizing sealed opaque envelopes, each containing the code corresponding to the assigned group for every participant. To ensure the integrity of the double-blind procedure, patients, clinical raters, and all personnel responsible for the clinical care of patients will remain uninformed about the assigned condition until the end point of study. Only cTBS administrators have access to the randomization list. The patients, clinical assessors, and all personnel responsible for clinical care remained blinded to group allocation.
After randomization, patients underwent 7 days of cTBS treatment and completed psychological evaluations and multimodal MRI scans at three time points: baseline, post-treatment, and follow-up. Baseline evaluations were conducted within 24 hours before the first cTBS session, while post-treatment and follow-up evaluations were performed 24 hours after the final cTBS session and four weeks later, respectively.
At each time point (baseline, post-treatment, and follow-up), trained evaluators conducted MRI scans and administered the following scales and behavioral paradigms:
Hamilton Anxiety Rating Scale (HAMA); Hamilton Depression Rating Scale (HAMD); Patient Health Questionnaire-15 (PHQ-15); Self-Rating Anxiety Scale (SAS); Insomnia Severity Index (ISI); MFTM-A (Cognitive Control Capacity); Attention Network Test (ANT).
These scales and paradigms were used to assess the severity of symptoms across different dimensions of anxiety. Additionally, demographic data, structural MRI (sMRI), and functional MRI (fMRI) data were collected at baseline. The sMRI data were utilized for real-time navigation during stimulation.
- Being tested
- Continuous theta-burst stimulation, sham continuous theta-burst stimulation
- Keywords
- Transcranial Magnetic Stimulation, anxiety, neuroimage
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous theta-burst stimulationOther
cTBS targets two regions: the dorsolateral prefrontal cortex (dlPFC) and the M1 area. Before the first treatment, each participant's resting motor threshold (RMT) will be determined using a five-step procedure for the primary motor cortex. RMT is defined as the minimum intensity required to elicit a motor response greater than 50 µV in at least 5 out of 10 consecutive trials in the right first dorsal interosseous muscle.
Participants will then undergo daily cTBS treatment three times a day for 7 consecutive days. Each stimulation session lasts 40 seconds, consisting of triplets of 50 Hz theta-burst stimulation repeated at 5 Hz, delivering a total of 600 pulses. Stimulation of the dlPFC target will be immediately followed by stimulation of the M1 target. To achieve cumulative aftereffects, the protocol will be repeated three times per day (a total of 3600 pulses/day) with two 15-minute breaks between sessions, timed with a stopwatch.
sham continuous theta-burst stimulationOther
The treatment pattern for the sham continuous theta-burst stimulation was similar to that for real stimulation. The sham coil is identical in appearance to the active coil, but it only produces sounds and sensations similar to those of the active coil on the scalp without generating a current, preventing participants from identifying their group assignment.
| Study group | Role | What they receive |
|---|---|---|
| active cTBS group | Active comparator | Dual-target active cTBS will be performed over 7 consecutive days Receives: Other: Continuous theta-burst stimulation |
| sham cTBS group | Sham comparator | Sham stimulation of dual-target cTBS was performed for 7 consecutive days using a sham coil Receives: Other: sham continuous theta-burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale (HAMA)
the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
Measured: 0week, 1week, 3week, 5week
Secondary outcomes (6)
Hamilton Depression Rating Scale (HAMD)
The Hamilton Depression Rating Scale (HAMD) is a widely-used clinician-rated tool for assessing depression severity. It evaluates mood, physical, and cognitive symptoms through 17-24 items scored 0-2 or 0-4, with total scores categorizing severity from normal (≤7) to severe (≥24).
Measured: 0week, 1week, 3week, 5week
Patient Health Questionnaire (PHQ-15)
the change of somatic symptoms will be assessed by Patient Health Questionnaire (PHQ-15). PHQ-15 is composed of 15 physical symptoms that have been extracted from the PHQ. PHQ-15 scale scores range from 0 to 30 points. Higher scores indicate more severe somatic symptoms.
Measured: 0week, 1week
Self-rating anxiety scale(SAS)
Self-rating anxiety scale(SAS) is a supplementary evaluation of the change of anxiety state of patients in this experiment, and it also belongs to the category of self-rating scale. Patients assessed anxiety by checking the frequency of 20 items: none or almost none, sometimes, most of the time, most of the time, or all of the time. SAS scale scores range from 0 to 100 points。The higher the score, the more serious the anxiety symptoms.
Measured: 0week, 1week
ISI(The insomnia severity index)
ISI(The insomnia severity index) is used to evaluate the changes of sleep status of anxiety patients in the recent (2 weeks), which is a self-rating scale. ISI scale scores range from 0 to 28 points. The higher the score is, the worse the sleep quality is. This scale indirectly reflects the changes of patients' anxiety state through evaluation.
Measured: 0week, 1week
Attention Network Test (ANT)
The Attention Network Test (ANT) is a computerized cognitive task designed to measure the efficiency of three distinct attention networks:
Alerting - The ability to achieve and maintain an alert state (measured by the benefit of cueing).
Orienting - The ability to selectively focus attention (measured by spatial cueing effects).
Executive Control - The ability to resolve conflict (measured by flanker interference effects).
Participants respond to a central target stimulus (e.g., an arrow direction) while ignoring distractors (flanker arrows). Reaction time differences between onditions quantify each network's efficiency. The ANT is widely used in cognitive neuroscience and clinical research to study attention deficits in disorders like ADHD, anxiety, and dementia.
Measured: 0week, 1week
MFTM-A (Cognitive Control Capacity)
The MFTM-A (Mental Flexibility Task Module - Adaptive) is a computerized cognitive test measuring executive control capacity, particularly mental flexibility. Using adaptive rule-switching tasks, it assesses:Switch costs (performance differences between rule shifts); Adaptive thresholds (max difficulty achieved); Error monitoring (correction rates). Widely applied in psychiatric research, it offers automated, sensitive evaluation of cognitive flexibility deficits.
Measured: 0week, 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Anhui Medical UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699706
- Sponsor's protocol ID
- AHMU-cTBS-anxiety
- Status last verified
- Aug 2025
- First submitted
- 19 Nov 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimage-guided Dual-target Continuous Theta Burst Stimulation for Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT06699706
- Acronym / sponsor ID
- AHMU-cTBS-anxiety
- Keywords
- Transcranial Magnetic Stimulation, anxiety, neuroimage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 21 Nov 2024 (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.
The aim of this clinical trial was to determine whether image-guided dual-target cTBS is effective for anxiety disorders. The main questions it aims to answer are:
- Does dual-target cTBS improve patients' anxiety symptoms?
- Does dual-target cTBS improve patients' somatization symptoms?
- Researchers will compare cTBS real and sham stimulation to determine whether cTBS is effective in treating anxiety disorders.
Participants will:
- Received either cTBS treatment or sham stimulation for 7 consecutive days
- Psychological assessment and MRI scan were performed before treatment, within 2 days, 2 weeks and 1 month after treatment
- Adverse reactions during the experiment were recorded
Detailed description
This was a randomized, double-blind, sham-controlled clinical trial. Patients with generalized anxiety disorder (GAD) were recruited from the Neurology Outpatient Clinic and Psychiatry Outpatient Clinic at the First Affiliated Hospital of Anhui Medical University, as well as the Psychiatry Outpatient Clinic and Inpatient Ward at the Second Affiliated Hospital of Anhui Medical University. The diagnosis of GAD was based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), independently confirmed by two professional psychiatrists. Patients meeting the inclusion criteria provided written informed consent and were randomly assigned to either a true cTBS treatment group or a sham stimulation group.
Patients will be randomly assigned to receive either active or sham cTBS treatments according to a computer-generated list by an unblinded investigator not involved with study ratings/analysis. The assignment will be executed by utilizing sealed opaque envelopes, each containing the code corresponding to the assigned group for every participant. To ensure the integrity of the double-blind procedure, patients, clinical raters, and all personnel responsible for the clinical care of patients will remain uninformed about the assigned condition until the end point of study. Only cTBS administrators have access to the randomization list. The patients, clinical assessors, and all personnel responsible for clinical care remained blinded to group allocation.
After randomization, patients underwent 7 days of cTBS treatment and completed psychological evaluations and multimodal MRI scans at three time points: baseline, post-treatment, and follow-up. Baseline evaluations were conducted within 24 hours before the first cTBS session, while post-treatment and follow-up evaluations were performed 24 hours after the final cTBS session and four weeks later, respectively.
At each time point (baseline, post-treatment, and follow-up), trained evaluators conducted MRI scans and administered the following scales and behavioral paradigms:
Hamilton Anxiety Rating Scale (HAMA); Hamilton Depression Rating Scale (HAMD); Patient Health Questionnaire-15 (PHQ-15); Self-Rating Anxiety Scale (SAS); Insomnia Severity Index (ISI); MFTM-A (Cognitive Control Capacity); Attention Network Test (ANT).
These scales and paradigms were used to assess the severity of symptoms across different dimensions of anxiety. Additionally, demographic data, structural MRI (sMRI), and functional MRI (fMRI) data were collected at baseline. The sMRI data were utilized for real-time navigation during stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active cTBS group | Active comparator | Other: Continuous theta-burst stimulationDual-target active cTBS will be performed over 7 consecutive days |
| sham cTBS group | Sham comparator | Other: sham continuous theta-burst stimulationSham stimulation of dual-target cTBS was performed for 7 consecutive days using a sham coil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for anxiety
- HAMA score ≥ 14 (HAMD score < 17).
- Age range: 18-60 years.
- Right-handed.
- Able to cooperate with the collection of general demographic information and neuropsychological testing.
Key exclusion criteria (4 listed)
- Presence of organic brain lesions detected on MRI.
- History of alcohol or drug dependence.
- Diagnosis of other neuropsychiatric disorders, such as epilepsy, autism, obsessive-compulsive disorder, or autoimmune encephalitis.
- Contraindications to MRI scanning.-
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 |
|---|---|---|
| Continuous theta-burst stimulationcTBS targets two regions: the dorsolateral prefrontal cortex (dlPFC) and the M1 area. Before the first treatment, each participant's resting motor threshold (RMT) will be determined using a five-step procedure for the primary motor cortex. RMT is defined as the minimum intensity required to elicit a motor response greater than 50 µV in at least 5 out of 10 consecutive trials in the right first dorsal interosseous muscle. Participants will then undergo daily cTBS treatment three times a day for 7 consecutive days. Each stimulation session lasts 40 seconds, consisting of triplets of 50 Hz theta-burst stimulation repeated at 5 Hz, delivering a total of 600 pulses. Stimulation of the dlPFC target will be immediately followed by stimulation of the M1 target. To achieve cumulative aftereffects, the protocol will be repeated three times per day (a total of 3600 pulses/day) with two 15-minute breaks between sessions, timed with a stopwatch. | Other | active cTBS group |
| sham continuous theta-burst stimulationThe treatment pattern for the sham continuous theta-burst stimulation was similar to that for real stimulation. The sham coil is identical in appearance to the active coil, but it only produces sounds and sensations similar to those of the active coil on the scalp without generating a current, preventing participants from identifying their group assignment. | Other | sham cTBS group |
Primary outcome
Hamilton Anxiety Rating Scale (HAMA)
Time frame: 0week, 1week, 3week, 5week
the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
6 secondary outcomes
Hamilton Depression Rating Scale (HAMD)
Time frame: 0week, 1week, 3week, 5week
Patient Health Questionnaire (PHQ-15)
Time frame: 0week, 1week
Self-rating anxiety scale(SAS)
Time frame: 0week, 1week
ISI(The insomnia severity index)
Time frame: 0week, 1week
Attention Network Test (ANT)
Time frame: 0week, 1week
MFTM-A (Cognitive Control Capacity)
Time frame: 0week, 1week
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 22 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous theta-burst stimulation in people with Anxiety and Transcranial Magnetic Stimulation Repetitive, run by Anhui Medical University at 1 site 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAMA) (time frame: 0week, 1week, 3week, 5week). 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 22 Aug 2025.