Accelerated iTBS for PTSD and Depression

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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. 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

Primary outcome measure(s)

• Recruitment rate — Study recruitment period, up to 12 months
  Recruitment rate will be assessed as the number of participants enrolled per month during the active recruitment period.
• Consent rate — Study recruitment period, up to 12 months
  Consent rate will be assessed as the proportion of eligible individuals approached who provide informed consent.
• Treatment adherence — Treatment Days 1 through 5
  Treatment adherence will be assessed as the percentage of scheduled accelerated iTBS sessions completed during the 5-day treatment course.
• Retention through Week 12 follow-up — Baseline through Week 12
  Retention will be assessed as the proportion of enrolled participants who complete the Week 12 follow-up visit.
• Adverse events — Treatment Days 1 through Week 12
  Adverse events will be assessed as the proportion of participants who experience one or more adverse events during treatment and follow-up.
• Serious adverse events — Treatment Days 1 through Week 12
  Serious adverse events will be assessed as the proportion of participants who experience one or more serious adverse events during treatment and follow-up.
• Discontinuations due to adverse events — Treatment Days 1 through Week 12
  Tolerability will be assessed as the proportion of participants who discontinue accelerated iTBS because of adverse events.
• Participant satisfaction with accelerated iTBS — Week 2, Week 5, and Week 12
  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.
• Participant feedback on accelerated iTBS — Week 2, Week 5, and Week 12
  Participant feedback will be assessed using brief feedback questions about the accelerated iTBS treatment schedule and overall study experience. Responses will be summarized descriptively.

Trial sites (1)

More Lawson Research Institute of St. Joseph's trials in Canada

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