Personalized and Accelerated Transcranial Magnetic Stimulation for Treatment-resistant Anxiety Related Disorders (I2Start)
31. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
24
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Phern Chern Tor, MBBS
- Telefonnummer: +65 6908 2222
- E-post: cip@nuhs.edu.sg
Studiesteder
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-
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Singapore, Singapore
- National University Hospital, Singapore
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Ta kontakt med:
- Phern Chern Tor, MBBS
- Telefonnummer: +65 6908 2222
- E-post: cip@nuhs.edu.sg
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Enhet: Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100
Magpro X100, Axilium Cobot, Localite Camera
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Beck Anxiety Inventory (BAI)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Beck Depression Inventory (BDI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Correlation of changes in functional connectivity with changes in BAI scores
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. desember 2029
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
31. august 2026
Først innsendt som oppfylte QC-kriteriene
31. august 2026
Først lagt ut (Faktiske)
3. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-0464
Plan for individuelle deltakerdata (IPD)
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