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NCT Number: NCT07801391

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

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.

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Key information

Conditions

Anxiety and Fear-Related Disorders Anxiety Disorders Mental Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100

Device

Magpro X100, Axilium Cobot, Localite Camera

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Phern Chern Tor, MBBS

CONTACT

[email protected]

+65 6908 2222

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National University of Singapore

Registry information

Acronym: I2Start

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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