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Accelerated iTBS for PTSD and Depression

15 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

16

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 0A7
        • Reclutamento
        • St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Radhika Kelkar, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Exploratory change in clinician-rated depression symptom severity measured by HAMD-17
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Lawson Research Institute of St. Joseph's

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

9 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AiTBS-PTSD-MDD--001
  • 127851 (Altro identificatore: Western HSREB Project ID)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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