Accelerated iTBS for PTSD and Depression

NCT07682207 | Not Yet Recruiting

• 2 other identifiers: AiTBS-PTSD-MDD--001127851
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Can participants complete six short brain stimulation sessions per day for five days?
2. 2.Is this treatment schedule safe and tolerable for participants?
3. 3.What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?
4. 4.Complete health screening and baseline assessments.
5. 5.Receive six short sessions of magnetic brain stimulation per day for five days.
6. 6.Have their brain activity measured using an EEG recording.
7. 7.Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.

Conditions

Post Traumatic Stress Disorder PTSD; Major Depressive Disorder (MDD)

Keywords

PTSD; MDD; Depression; Feasibility study; Accelerated intermittent theta burst stimulation; iTBS; Theta burst stimulation; Transcranial magnetic stimulation; TMS; Brain stimulation; EEG

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (12)

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

  Baseline, Week 2, Week 5, and Week 12

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

  Baseline, Week 2, Week 5, and Week 12

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

  Baseline, Week 2, Week 5, and Week 12

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

  Baseline, Week 2, and Week 12

• Exploratory change in anxiety symptom severity measured by GAD-7

  Baseline, Week 2, Week 5, and Week 12

Study Arms (1)

Accelerated iTBS

EXPERIMENTAL

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

Interventions

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.

Accelerated iTBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

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

London, Ontario, N6C 0A7, Canada

Location

MeSH Terms

Conditions

Combat Disorders; Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Radhika Kelkar, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radhika Kelkar, MD

CONTACT

519-685-8500; radhika.kelkar@lhsc.on.ca

Mervin Blair, PhD, C.Psych

CONTACT

519-646-6100; mervin.blair@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm pilot feasibility study evaluating an intensive accelerated iTBS protocol.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: July 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)