Accelerated iTBS for PTSD and Depression

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder (MDD); Post Traumatic Stress Disorder PTSD
• Intervention / Treatment: Device: Accelerated intermittent theta burst stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Radhika Kelkar, MD; Phone Number: 75805 519-685-8500; Email: radhika.kelkar@lhsc.on.ca
• Study Contact Backup: Name: Mervin Blair, PhD, C.Psych; Phone Number: 48170 519-646-6100; Email: mervin.blair@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6C 0A7
      • St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building
      • Contact: Radhika Kelkar, MD; Phone Number: 75805 519-685-8500; Email: radhika.kelkar@lhsc.on.ca
      • Contact: Mervin Blair, PhD, C.Psych; Phone Number: 48170 519-646-6100; Email: mervin.blair@sjhc.london.on.ca
      • Principal Investigator: Radhika Kelkar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	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	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	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	Retention will be assessed as the proportion of enrolled participants who complete the Week 12 follow-up visit.	Baseline through Week 12
Adverse events	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	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory change in clinician-rated depression symptom severity measured by HAMD-17	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	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	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Lawson Research Institute of St. Joseph's
• Investigators: Principal Investigator: Radhika Kelkar, MD, St. Joseph's Health Care London, Parkwood Institute, Finch Family Mental Health Care Building

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Depression; MDD; Transcranial magnetic stimulation; EEG; TMS; Feasibility study; Brain stimulation; iTBS; Theta burst stimulation; Accelerated intermittent theta burst stimulation
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Mood Disorders; Stress Disorders, Traumatic; Depressive Disorder; Behavior; Depression; Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Combat Disorders
• Other Study ID Numbers: AiTBS-PTSD-MDD--001; 127851 (Other Identifier: Western HSREB Project ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No