Accelerated iTBS for PTSD and Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLawson Research Institute of St. Joseph's
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Accelerated intermittent theta burst stimulation
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov