Personalized and Accelerated Transcranial Magnetic Stimulation for Treatment-resistant Anxiety Related Disorders (I2Start)

August 31, 2026 updated by: National University Hospital, Singapore
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Phern Chern Tor, MBBS
  • Phone Number: +65 6908 2222
  • Email: cip@nuhs.edu.sg

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital, Singapore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized neuronavigated intermittent theta burst stimulation (MagPro X100) system for anxiety
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.
Device: Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100
Magpro X100, Axilium Cobot, Localite Camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI)
Time Frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of changes in functional connectivity with changes in BAI scores
Time Frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
The investigators will perform additional exploratory post-hoc analyses by analysing brain imaging changes before and after TMS treatment.
Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

National University of Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

August 31, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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