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Accelerated iTBS for PTSD and Depression

15 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

16

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Kanada
    • Ontario
      • London, Ontario, Kanada, N6C 0A7
        • Rekrutacyjny
        • St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Radhika Kelkar, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Recruitment rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Exploratory change in clinician-rated depression symptom severity measured by HAMD-17
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Lawson Research Institute of St. Joseph's

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2027

Ukończenie studiów (Szacowany)

1 września 2027

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

2 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • AiTBS-PTSD-MDD--001
  • 127851 (Inny identyfikator: Western HSREB Project ID)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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