Major Depressive Disorder (MDD), Post Traumatic Stress Disorder PTSD
Conditions
Keywords
PTSD, MDD, Depression, Feasibility study, Accelerated intermittent theta burst stimulation, iTBS, Theta burst stimulation, Transcranial magnetic stimulation, TMS, Brain stimulation, EEG
Brief 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.
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
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.
Sponsors
Lawson Research Institute of St. Joseph's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm pilot feasibility study evaluating an intensive accelerated iTBS protocol.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory change in cognitive function measured by MoCA | Baseline, Week 2, Week 5, and Week 12 | Cognitive function will be assessed using the Montreal Cognitive Assessment. Total scores range from 0 to 30, with higher scores indicating better cognitive function. |
| Exploratory change in functioning and disability measured by WHODAS 2.0 | Baseline, Week 2, Week 5, and Week 12 | Functioning and disability will be assessed using the WHO Disability Assessment Schedule 2.0 |
| Baseline clinical global severity measured by CGI-S | Baseline | Clinical global severity will be assessed using the Clinical Global Impression-Severity scale. Scores range from 1 to 7, with higher scores indicating greater illness severity. |
| Exploratory change in quality of life measured by Q-LES-Q-SF | Baseline, Week 2, Week 5, and Week 12 | Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form. |
| Exploratory change in clinical global improvement measured by CGI-I | Week 2, Week 5, and Week 12 | Clinical global improvement will be assessed using the Clinical Global Impression-Improvement scale. Scores range from 1 to 7, with lower scores indicating greater clinical improvement. |
| Exploratory change in resting-state EEG alpha power | Baseline, Treatment Day 1, and Treatment Day 5 | Resting-state EEG alpha power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS. |
| Exploratory change in resting-state EEG gamma power | Baseline, Treatment Day 1, and Treatment Day 5 | Resting-state EEG gamma power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS. |
| Exploratory change in clinician-rated depression symptom severity measured by HAMD-17 | Baseline, Week 2, Week 5, and Week 12 | Clinician-rated depression symptom severity will be assessed using the Hamilton Depression Rating Scale-17. Total scores range from 0 to 52, with higher scores indicating greater depression symptom severity. |
| Exploratory change in self-reported depression symptom severity measured by PHQ-9 | Baseline, Week 2, Week 5, and Week 12 | Self-reported depression symptom severity will be assessed using the Patient Health Questionnaire-9. Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity. |
| Exploratory change in self-reported PTSD symptom severity measured by PCL-5 | Baseline, Week 2, Week 5, and Week 12 | Self-reported PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity. |
| Exploratory change in clinician-rated PTSD symptom severity measured by CAPS-5 | Baseline, Week 2, and Week 12 | Clinician-rated PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5. Total symptom severity scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity. |
| Exploratory change in anxiety symptom severity measured by GAD-7 | Baseline, Week 2, Week 5, and Week 12 | Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 item Scale. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity. |
Countries
Canada
Contacts
CONTACTRadhika Kelkar, MD
CONTACTMervin Blair, PhD, C.Psych
PRINCIPAL_INVESTIGATORRadhika Kelkar, MD
St. Joseph's Health Care London, Parkwood Institute, Finch Family Mental Health Care Building
Outcome results
None listed