Anxiety and Fear-Related DisordersI2StartNCT07801391
Personalized and Accelerated Transcranial Magnetic Stimulation for Treatment-resistant Anxiety Related Disorders
A study testing Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100 in people with Anxiety and Fear-Related Disorders, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This proposal seeks to carry out an open-label single arm study to examine the neurobehavioral changes induced by personalized, causal network mapping guided accelerated intermittent theta burst stimulation (aiTBS) in patients with treatment-resistant anxiety-related disorders. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Anxiety and Fear-Related Disorders
- What is being tested?
- Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2026to Dec 2029
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/ female aged ≥ 21 years and ≤ 70 years
- Diagnosis of an anxiety-related disorder as validated by the MINI (Specifically, the types of anxiety-related disorders are: generalized anxiety disorder; panic disorderl social anxiety disorder; obsessive compulsive disorder; post-traumatic stress disorder; agoraphobia; anxiety disorder due to another medical condition; other specified anxiety disorders; and unspecified anxiety disorder.)
- Non-response to adequate trial (4 weeks) of at least two anxiety medication as verified by the study clinician, or psychotherapy for anxiety
- BAI score of 16 or above
- Able to give informed consent
- Able to understand English
Who cannot join
- DSM-5 psychotic disorder
- Significant personality disorder which may hinder the progress of this study
- Drug or alcohol abuse or dependency (preceding 3 months)
- Rapid clinical response required, e.g., high suicide risk
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
- Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pumps or any other electronic implants/ devices
Show all 13Show fewer
- Tattoos containing derromagnetic ink or permanent piercings
- Currently wearing dental braces
- Pregnancy
- Unsuitable for MRI or TMS for any other reasons
- With recent TMS or ECT treatment within the past 3 months
- Currently on multiple stimulant medications (2 or more)
- Participant does not have the capacity to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
National University Hospital, Singapore
Singapore
Phern Chern Tor, MBBS, +65 6908 2222, cip@nuhs.edu.sg
About this study
This proposal seeks to carry out an open-label single arm study to examine the neurobehavioral changes induced by personalized, causal network mapping guided accelerated intermittent theta burst stimulation (aiTBS) in patients with treatment-resistant anxiety-related disorders.
- Conditions
- Anxiety and Fear-Related Disorders
- Being tested
- Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100
- Keywords
- Anxiety, Neuronavigated, iTBS, Accelerated
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100Device
Magpro X100, Axilium Cobot, Localite Camera
| Study group | Role | What they receive |
|---|---|---|
| Individualized neuronavigated intermittent theta burst stimulation (MagPro X100) system for anxiety | Experimental | Participants will receive an accelerated intermittent theta burst stimulation (iTBS) treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 6 treatment sessions daily for 5 consecutive workdays for a total of 30 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines. Receives: Device: Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory (BAI)
The primary outcome will be the response rate as defined as ≥50% reduction from baseline BAI scores pre- and post-iTBS treatment. BAI is an ordinal self-report scale measuring physical and cognitive anxiety symptoms ranging from 0-63. Higher scores mean worse outcome.
Measured: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Secondary outcomes (6)
Beck Depression Inventory (BDI)
Change in BDI scores pre- and post-iTBS treatment. BDI is an ordinal self-report scale measuring depressive symptoms ranging from 0-63. Higher scores mean worse outcome.
Measured: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Penn State Worry Questionnaire (PSWQ)
Change in PSWQ scores pre- and post-iTBS treatment. PSWQ is an ordinal self-report scale measuring pathological worry ranging from 16-80. Scores depend on whether the item is worded positively or negatively.
Measured: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Mini-Mood and Anxiety Symptom Questionnaire (Mini-MASQ)
Change in Mini-MASQ scores pre- and post-iTBS treatment. The Mini-MASQ is an orginal self-report scale measuring symptoms of anxiety and depression. Scores depend on whether the item is worded positively or negatively.
Measured: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Hamilton Anxiety Rating Scale (HAM-A)
Change in HAM-A scores pre- and post-iTBS treatment. HAM-A is an ordinal clinician-rated scale measuring severity of psychic and somatic anxiety, ranging from 0-56. Higher scores mean a worse outcome.
Measured: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Inventory of Depression and Anxiety Symptoms-II (IDAS-II)
Change in IDAS-II scores pre- and post-iTBS treatment. IDAS-II is an ordinal self-report scale measuring depression, anxiety, and bipolar symptoms ranging from 99-495. Higher scores mean worse outcome.
Measured: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Sheehan Disability Scale (SDS)
Change in SDS scores pre- and post-iTBS treatment. SDS is an ordinal self-report scale measuring how symptoms affect functional imapirment across work/ school, social life, and family/ home responsibilities, ranging from 0-10 for each domain. Higher scores mean a worse outcome.
Measured: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and Fear-Related DisordersStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801391
- Sponsor's protocol ID
- 2026-0464
- Acronym
- I2Start
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized and Accelerated Transcranial Magnetic Stimulation for Treatment-resistant Anxiety Related Disorders
- ClinicalTrials.gov ID
- NCT07801391
- Acronym / sponsor ID
- I2Start / 2026-0464
- Conditions
- Anxiety and Fear-Related Disorders
- Keywords
- Anxiety, Neuronavigated, iTBS, Accelerated
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Sep 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 proposal seeks to carry out an open-label single arm study to examine the neurobehavioral changes induced by personalized, causal network mapping guided accelerated intermittent theta burst stimulation (aiTBS) in patients with treatment-resistant anxiety-related disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized neuronavigated intermittent theta burst stimulation (MagPro X100) system for anxiety | Experimental | Device: Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100Participants will receive an accelerated intermittent theta burst stimulation (iTBS) treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 6 treatment sessions daily for 5 consecutive workdays for a total of 30 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male/ female aged ≥ 21 years and ≤ 70 years
- Diagnosis of an anxiety-related disorder as validated by the MINI (Specifically, the types of anxiety-related disorders are: generalized anxiety disorder; panic disorderl social anxiety disorder; obsessive compulsive disorder; post-traumatic stress disorder; agoraphobia; anxiety disorder due to another medical condition; other specified anxiety disorders; and unspecified anxiety disorder.)
- Non-response to adequate trial (4 weeks) of at least two anxiety medication as verified by the study clinician, or psychotherapy for anxiety
- BAI score of 16 or above
- Able to give informed consent
Key exclusion criteria (13 listed)
- DSM-5 psychotic disorder
- Significant personality disorder which may hinder the progress of this study
- Drug or alcohol abuse or dependency (preceding 3 months)
- Rapid clinical response required, e.g., high suicide risk
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
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 |
|---|---|---|
| Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100Magpro X100, Axilium Cobot, Localite Camera | Device | Individualized neuronavigated intermittent theta burst stimulation (MagPro X100) system for anxiety |
Primary outcome
Beck Anxiety Inventory (BAI)
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
The primary outcome will be the response rate as defined as ≥50% reduction from baseline BAI scores pre- and post-iTBS treatment. BAI is an ordinal self-report scale measuring physical and cognitive anxiety symptoms ranging from 0-63. Higher scores mean worse outcome.
6 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Penn State Worry Questionnaire (PSWQ)
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Mini-Mood and Anxiety Symptom Questionnaire (Mini-MASQ)
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Inventory of Depression and Anxiety Symptoms-II (IDAS-II)
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Sheehan Disability Scale (SDS)
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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 3 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100 in people with Anxiety and Fear-Related Disorders, run by National University Hospital, Singapore at 1 site in Singapore.
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 13 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 3 Sep 2026. 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 Singapore. 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. 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 Phern Chern Tor, MBBS (+65 6908 2222, cip@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (BAI) (time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.). 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 3 Sep 2026.