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Accelerated iTBS for PTSD and Depression

26 de junio de 2026 actualizado por: Lawson Research Institute of St. Joseph's

Accelerated Intermittent Theta Burst Stimulation for Depression in Post-Traumatic Stress Disorder: A Single-Arm, Open-Label Feasibility Study

The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).

The main questions this study aims to answer are:

  1. Can participants complete six short brain stimulation sessions per day for five days?
  2. Is this treatment schedule safe and tolerable for participants?
  3. What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?

Participants will:

  1. Complete health screening and baseline assessments.
  2. Receive six short sessions of magnetic brain stimulation per day for five days.
  3. Have their brain activity measured using an EEG recording.
  4. Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a single-arm, open-label pilot feasibility study of accelerated intermittent theta burst stimulation, also called accelerated iTBS, in adults with both post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). The study is designed to assess whether an accelerated iTBS schedule can be delivered safely, tolerably, and feasibly in a clinical setting. The main focus is feasibility, including recruitment, treatment adherence, participant retention, safety, tolerability, and participant acceptability. About 12 to 16 participants will receive active accelerated iTBS. Treatment will include six short stimulation sessions per day over five consecutive days, for a total of 30 sessions. The study will also collect exploratory information over time on depression symptoms, PTSD symptoms, anxiety, daily functioning, quality of life, and brain activity measured by EEG. Because this is a small pilot study, the analysis will be mainly descriptive. The results will help refine study procedures and guide the design of a larger future clinical trial.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

16

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

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Canadá
    • Ontario
      • London, Ontario, Canadá, N6C 0A7
        • St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Radhika Kelkar, MD

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:

  • Adults aged 18 years or older.
  • Current post-traumatic stress disorder (PTSD) and current major depressive disorder (MDD), confirmed by a structured diagnostic interview (e.g., MINI 6.0 using the PTSD and MDD modules).
  • Minimum symptom severity at baseline: HAMD-17 score ≥14 (moderate depression) and/or PCL-5 score ≥33 (probable PTSD).
  • On a stable pharmacologic and/or psychotherapeutic regimen for at least 4 weeks prior to baseline, and willing to maintain stability during the treatment phase, unless medically necessary.
  • Capacity to provide informed consent and comply with study procedures and visits at St. Joseph's Health Care, London/Parkwood Institute.
  • Sufficient English proficiency to complete consent and study assessments.

Exclusion Criteria:

  • Neurologic or device-related risks, including seizure history, traumatic brain injury with loss of consciousness greater than 5 minutes, major neurologic illness, or metal/electronic implants contraindicated for transcranial magnetic stimulation.
  • Psychiatric or substance-related risks, including current psychotic disorder, acute mania, diagnosis of Bipolar I or Bipolar II disorder, recent substance use disorder, or imminent suicide risk.
  • Medical or medication-related risks, including unstable severe illness, high-risk medications, hearing impairment, unwillingness to use ear protection, or prior non-response to an adequate course of theta burst stimulation for the current depression/PTSD episode.
  • Enrollment in another interventional trial.
  • Inability to comply with the study schedule.

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
Experimental: Accelerated iTBS
Participants will receive active accelerated intermittent theta burst stimulation (iTBS). Treatment will consist of six short stimulation sessions per day delivered over five consecutive days, for a total of 30 sessions.
Dispositivo: Accelerated intermittent theta burst stimulation
Accelerated intermittent theta burst stimulation, also called accelerated iTBS, is a non-invasive magnetic brain stimulation intervention. Stimulation is delivered to the left dorsolateral prefrontal cortex using a transcranial magnetic stimulation system. Participants receive six short sessions per day over five consecutive days.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment rate
Periodo de tiempo: Study recruitment period, up to 12 months
Recruitment rate will be assessed as the number of participants enrolled per month during the active recruitment period.
Study recruitment period, up to 12 months
Consent rate
Periodo de tiempo: Study recruitment period, up to 12 months
Consent rate will be assessed as the proportion of eligible individuals approached who provide informed consent.
Study recruitment period, up to 12 months
Treatment adherence
Periodo de tiempo: Treatment Days 1 through 5
Treatment adherence will be assessed as the percentage of scheduled accelerated iTBS sessions completed during the 5-day treatment course.
Treatment Days 1 through 5
Retention through Week 12 follow-up
Periodo de tiempo: Baseline through Week 12
Retention will be assessed as the proportion of enrolled participants who complete the Week 12 follow-up visit.
Baseline through Week 12
Adverse events
Periodo de tiempo: Treatment Days 1 through Week 12
Adverse events will be assessed as the proportion of participants who experience one or more adverse events during treatment and follow-up.
Treatment Days 1 through Week 12
Serious adverse events
Periodo de tiempo: Treatment Days 1 through Week 12
Serious adverse events will be assessed as the proportion of participants who experience one or more serious adverse events during treatment and follow-up.
Treatment Days 1 through Week 12
Discontinuations due to adverse events
Periodo de tiempo: Treatment Days 1 through Week 12
Tolerability will be assessed as the proportion of participants who discontinue accelerated iTBS because of adverse events.
Treatment Days 1 through Week 12
Participant satisfaction with accelerated iTBS
Periodo de tiempo: Week 2, Week 5, and Week 12
Participant satisfaction will be assessed using a 5-point Likert satisfaction rating scale. Scores range from 1 to 5, with higher scores indicating greater satisfaction.
Week 2, Week 5, and Week 12
Participant feedback on accelerated iTBS
Periodo de tiempo: Week 2, Week 5, and Week 12
Participant feedback will be assessed using brief feedback questions about the accelerated iTBS treatment schedule and overall study experience. Responses will be summarized descriptively.
Week 2, Week 5, and Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Exploratory change in clinician-rated depression symptom severity measured by HAMD-17
Periodo de tiempo: Baseline, Week 2, Week 5, and Week 12
Clinician-rated depression symptom severity will be assessed using the Hamilton Depression Rating Scale-17. Total scores range from 0 to 52, with higher scores indicating greater depression symptom severity.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in self-reported depression symptom severity measured by PHQ-9
Periodo de tiempo: Baseline, Week 2, Week 5, and Week 12
Self-reported depression symptom severity will be assessed using the Patient Health Questionnaire-9. Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in self-reported PTSD symptom severity measured by PCL-5
Periodo de tiempo: Baseline, Week 2, Week 5, and Week 12
Self-reported PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in clinician-rated PTSD symptom severity measured by CAPS-5
Periodo de tiempo: Baseline, Week 2, and Week 12
Clinician-rated PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5. Total symptom severity scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Baseline, Week 2, and Week 12
Exploratory change in anxiety symptom severity measured by GAD-7
Periodo de tiempo: Baseline, Week 2, Week 5, and Week 12
Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 item Scale. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in cognitive function measured by MoCA
Periodo de tiempo: Baseline, Week 2, Week 5, and Week 12
Cognitive function will be assessed using the Montreal Cognitive Assessment. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in functioning and disability measured by WHODAS 2.0
Periodo de tiempo: Baseline, Week 2, Week 5, and Week 12
Functioning and disability will be assessed using the WHO Disability Assessment Schedule 2.0
Baseline, Week 2, Week 5, and Week 12
Exploratory change in quality of life measured by Q-LES-Q-SF
Periodo de tiempo: Baseline, Week 2, Week 5, and Week 12
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form.
Baseline, Week 2, Week 5, and Week 12
Baseline clinical global severity measured by CGI-S
Periodo de tiempo: Baseline
Clinical global severity will be assessed using the Clinical Global Impression-Severity scale. Scores range from 1 to 7, with higher scores indicating greater illness severity.
Baseline
Exploratory change in clinical global improvement measured by CGI-I
Periodo de tiempo: Week 2, Week 5, and Week 12
Clinical global improvement will be assessed using the Clinical Global Impression-Improvement scale. Scores range from 1 to 7, with lower scores indicating greater clinical improvement.
Week 2, Week 5, and Week 12
Exploratory change in resting-state EEG alpha power
Periodo de tiempo: Baseline, Treatment Day 1, and Treatment Day 5
Resting-state EEG alpha power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
Baseline, Treatment Day 1, and Treatment Day 5
Exploratory change in resting-state EEG gamma power
Periodo de tiempo: Baseline, Treatment Day 1, and Treatment Day 5
Resting-state EEG gamma power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
Baseline, Treatment Day 1, and Treatment Day 5

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Lawson Research Institute of St. Joseph's

Investigadores

  • Investigador principal: Radhika Kelkar, MD, St. Joseph's Health Care London, Parkwood Institute, Finch Family Mental Health Care Building

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 julio de 2026

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

9 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de junio de 2026

Publicado por primera vez (Actual)

2 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AiTBS-PTSD-MDD--001
  • 127851 (Otro identificador: Western HSREB Project ID)

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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