Personalized and Accelerated Transcranial Magnetic Stimulation for Treatment-resistant Anxiety Related Disorders (I2Start)
31 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
24
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Phern Chern Tor, MBBS
- Número de teléfono: +65 6908 2222
- Correo electrónico: cip@nuhs.edu.sg
Ubicaciones de estudio
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Singapore, Singapur
- National University Hospital, Singapore
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Contacto:
- Phern Chern Tor, MBBS
- Número de teléfono: +65 6908 2222
- Correo electrónico: cip@nuhs.edu.sg
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Beck Anxiety Inventory (BAI)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Beck Depression Inventory (BDI)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Correlation of changes in functional connectivity with changes in BAI scores
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2029
Finalización del estudio (Estimado)
1 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
31 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de agosto de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-0464
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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