Accelerated iTBS for PTSD and Depression

Official title

Accelerated Intermittent Theta Burst Stimulation for Depression in Post-Traumatic Stress Disorder: A Single-Arm, Open-Label Feasibility Study

Overview

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.

Detailed description

This is a single-arm, open-label pilot feasibility study of accelerated intermittent theta burst stimulation, also called accelerated iTBS, in adults with both post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). The study is designed to assess whether an accelerated iTBS schedule can be delivered safely, tolerably, and feasibly in a clinical setting. The main focus is feasibility, including recruitment, treatment adherence, participant retention, safety, tolerability, and participant acceptability. About 12 to 16 participants will receive active accelerated iTBS. Treatment will include six short stimulation sessions per day over five consecutive days, for a total of 30 sessions. The study will also collect exploratory information over time on depression symptoms, PTSD symptoms, anxiety, daily functioning, quality of life, and brain activity measured by EEG. Because this is a small pilot study, the analysis will be mainly descriptive. The results will help refine study procedures and guide the design of a larger future clinical trial.

Interventions

• Device 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.

Primary outcome measures

• Recruitment rate [Time frame: Study recruitment period, up to 12 months]
• Consent rate [Time frame: Study recruitment period, up to 12 months]
• Treatment adherence [Time frame: Treatment Days 1 through 5]
• Retention through Week 12 follow-up [Time frame: Baseline through Week 12]
• Adverse events [Time frame: Treatment Days 1 through Week 12]
• Serious adverse events [Time frame: Treatment Days 1 through Week 12]
• Discontinuations due to adverse events [Time frame: Treatment Days 1 through Week 12]
• Participant satisfaction with accelerated iTBS [Time frame: Week 2, Week 5, and Week 12]
• Participant feedback on accelerated iTBS [Time frame: Week 2, Week 5, and Week 12]

Secondary outcome measures (12)

• Exploratory change in clinician-rated depression symptom severity measured by HAMD-17 [Time frame: Baseline, Week 2, Week 5, and Week 12]
• Exploratory change in self-reported depression symptom severity measured by PHQ-9 [Time frame: Baseline, Week 2, Week 5, and Week 12]
• Exploratory change in self-reported PTSD symptom severity measured by PCL-5 [Time frame: Baseline, Week 2, Week 5, and Week 12]
• Exploratory change in clinician-rated PTSD symptom severity measured by CAPS-5 [Time frame: Baseline, Week 2, and Week 12]
• Exploratory change in anxiety symptom severity measured by GAD-7 [Time frame: Baseline, Week 2, Week 5, and Week 12]
• Exploratory change in cognitive function measured by MoCA [Time frame: Baseline, Week 2, Week 5, and Week 12]
• Exploratory change in functioning and disability measured by WHODAS 2.0 [Time frame: Baseline, Week 2, Week 5, and Week 12]
• Exploratory change in quality of life measured by Q-LES-Q-SF [Time frame: Baseline, Week 2, Week 5, and Week 12]
• Baseline clinical global severity measured by CGI-S [Time frame: Baseline]
• Exploratory change in clinical global improvement measured by CGI-I [Time frame: Week 2, Week 5, and Week 12]
• Exploratory change in resting-state EEG alpha power [Time frame: Baseline, Treatment Day 1, and Treatment Day 5]
• Exploratory change in resting-state EEG gamma power [Time frame: Baseline, Treatment Day 1, and Treatment Day 5]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

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

Identifiers

NCT: NCT07682207 · AiTBS-PTSD-MDD--001 · 127851

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗