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

31. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Phern Chern Tor, MBBS
  • Telefonnummer: +65 6908 2222
  • E-mail: cip@nuhs.edu.sg

Studiesteder

  • Singapore
      • Singapore, Singapore
        • National University Hospital, Singapore
        • Kontakt:
          • Phern Chern Tor, MBBS
          • Telefonnummer: +65 6908 2222
          • E-mail: cip@nuhs.edu.sg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100
Magpro X100, Axilium Cobot, Localite Camera

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Beck Anxiety Inventory (BAI)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Beck Depression Inventory (BDI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation of changes in functional connectivity with changes in BAI scores
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National University Hospital, Singapore

Samarbejdspartnere

National University of Singapore

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. december 2029

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

31. august 2026

Først indsendt, der opfyldte QC-kriterier

31. august 2026

Først opslået (Faktiske)

3. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-0464

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