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

NCT07801391 | Not Yet Recruiting

• 1 other identifier: 2026-0464
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety and Fear-Related Disorders

Keywords

Anxiety; Neuronavigated; iTBS; Accelerated

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

Secondary Outcomes (6)

• Beck Depression Inventory (BDI)

  Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

• Penn State Worry Questionnaire (PSWQ)

  Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

• Mini-Mood and Anxiety Symptom Questionnaire (Mini-MASQ)

  Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

• Hamilton Anxiety Rating Scale (HAM-A)

  Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

• Inventory of Depression and Anxiety Symptoms-II (IDAS-II)

  Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

Other Outcomes (1)

• Correlation of changes in functional connectivity with changes in BAI scores

  Baseline, immediately post-treatment, 1-month and 3-months post-intervention.

Study Arms (1)

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.

Device: Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100

Interventions

Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100 DEVICE

Magpro X100, Axilium Cobot, Localite Camera

Individualized neuronavigated intermittent theta burst stimulation (MagPro X100) system for anxiety

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital, Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Phern Chern Tor, MBBS

CONTACT

+65 6908 2222; cip@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)