Accelerated iTBS for PTSD and Depression

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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.

Where this trial is running

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

Who to contact

Radhika Kelkar, MD · 519-685-8500 · radhika.kelkar@lhsc.on.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07682207.