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NCT Number: NCT07682207

Accelerated iTBS for PTSD and Depression

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.

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Key information

Conditions

Post Traumatic Stress Disorder PTSD Behavior Behavioral Symptoms Combat Disorders Depression Depressive Disorder Depressive Disorder, Major Major Depressive Disorder (MDD) Mental Disorders Mood Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building

London, Ontario, N6C 0A7, Canada

Location contact

Mervin Blair, PhD, C.Psych

CONTACT

[email protected]

519-646-6100 ext. 48170

Radhika Kelkar, MD

CONTACT

[email protected]

519-685-8500 ext. 75805

Radhika Kelkar, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Accelerated intermittent theta burst stimulation

Device

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 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.

  2. Consent rate

    Time frame: Study recruitment period, up to 12 months

    Consent rate will be assessed as the proportion of eligible individuals approached who provide informed consent.

  3. Treatment adherence

    Time frame: 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.

  4. Retention through Week 12 follow-up

    Time frame: Baseline through Week 12

    Retention will be assessed as the proportion of enrolled participants who complete the Week 12 follow-up visit.

  5. Adverse events

    Time frame: 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.

  6. Serious adverse events

    Time frame: 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.

  7. Discontinuations due to adverse events

    Time frame: Treatment Days 1 through Week 12

    Tolerability will be assessed as the proportion of participants who discontinue accelerated iTBS because of adverse events.

  8. Participant satisfaction with accelerated iTBS

    Time frame: 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.

  9. Participant feedback on accelerated iTBS

    Time frame: 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.

Secondary outcomes

  1. Exploratory change in clinician-rated depression symptom severity measured by HAMD-17

    Time frame: 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.

  2. Exploratory change in self-reported depression symptom severity measured by PHQ-9

    Time frame: 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.

  3. Exploratory change in self-reported PTSD symptom severity measured by PCL-5

    Time frame: 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.

  4. Exploratory change in clinician-rated PTSD symptom severity measured by CAPS-5

    Time frame: 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.

  5. Exploratory change in anxiety symptom severity measured by GAD-7

    Time frame: 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.

  6. Exploratory change in cognitive function measured by MoCA

    Time frame: 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.

  7. Exploratory change in functioning and disability measured by WHODAS 2.0

    Time frame: Baseline, Week 2, Week 5, and Week 12

    Functioning and disability will be assessed using the WHO Disability Assessment Schedule 2.0

  8. Exploratory change in quality of life measured by Q-LES-Q-SF

    Time frame: 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.

  9. Baseline clinical global severity measured by CGI-S

    Time frame: 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.

  10. Exploratory change in clinical global improvement measured by CGI-I

    Time frame: 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.

  11. Exploratory change in resting-state EEG alpha power

    Time frame: 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.

  12. Exploratory change in resting-state EEG gamma power

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mervin Blair, PhD, C.Psych

CONTACT

[email protected]

519-646-6100 ext. 48170

Radhika Kelkar, MD

CONTACT

[email protected]

519-685-8500 ext. 75805

Sponsors and collaborators

Lead sponsor

Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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