Faster brain stimulation for PTSD and depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small, single-arm feasibility study of accelerated intermittent theta burst stimulation in adults with comorbid PTSD and MDD. Participants receive six brief brain stimulation sessions per day for five consecutive days (30 sessions total) to evaluate safety, tolerability, adherence, and acceptability in a real-world clinical setting. The study collects exploratory data on changes in depression and PTSD symptoms, anxiety, daily functioning, quality of life, and EEG brain activity over time, with post-treatment assessments at week 2 and follow-up. Enrollment aims for roughly 12 to 16 participants, and analyses will be descriptive to inform the design of a larger trial. This study prioritizes feasibility over definitive efficacy conclusions.

Why it matters

Who can join: the full rules

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.

Where it's running

• St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Radhika Kelkar, MD — St. Joseph's Health Care London, Parkwood Institute, Finch Family Mental Health Care Building
• Study coordinator: Radhika Kelkar, MD
• Email: radhika.kelkar@lhsc.on.ca
• Phone: 519-685-8500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.