Personalized and Accelerated Transcranial Magnetic Stimulation for Treatment-resistant Anxiety Related Disorders (I2Start)
31 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
24
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Phern Chern Tor, MBBS
- Telefoonnummer: +65 6908 2222
- E-mail: cip@nuhs.edu.sg
Studie Locaties
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Singapore, Singapore
- National University Hospital, Singapore
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Contact:
- Phern Chern Tor, MBBS
- Telefoonnummer: +65 6908 2222
- E-mail: cip@nuhs.edu.sg
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Magpro X100, Axilium Cobot, Localite Camera
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Beck Anxiety Inventory (BAI)
Tijdsspanne: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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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.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Beck Depression Inventory (BDI)
Tijdsspanne: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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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.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Penn State Worry Questionnaire (PSWQ)
Tijdsspanne: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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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.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Mini-Mood and Anxiety Symptom Questionnaire (Mini-MASQ)
Tijdsspanne: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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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.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Hamilton Anxiety Rating Scale (HAM-A)
Tijdsspanne: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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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.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Inventory of Depression and Anxiety Symptoms-II (IDAS-II)
Tijdsspanne: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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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.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Sheehan Disability Scale (SDS)
Tijdsspanne: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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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.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Correlation of changes in functional connectivity with changes in BAI scores
Tijdsspanne: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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The investigators will perform additional exploratory post-hoc analyses by analysing brain imaging changes before and after TMS treatment.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 december 2029
Studie voltooiing (Geschat)
1 december 2029
Studieregistratiedata
Eerst ingediend
31 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
31 augustus 2026
Eerst geplaatst (Werkelijk)
3 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 september 2026
Laatste update ingediend die voldeed aan QC-criteria
31 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-0464
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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