Stress Disorders, Post-Traumatic Clinical Trial
— PTSDOfficial title:
Pathophysiological Understanding and Treatment of PTSD: an rTMS Approach
NCT number | NCT03840369 |
Other study ID # | REB18-1976 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | March 18, 2022 |
Verified date | May 2022 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In Canada, the prevalence of PTSD is approximately 12%, similar to Canadian military personnel. Current treatments for PTSD are limited in efficacy and durability - indicating a dire need for novel interventions in this population. Transcranial magnetic stimulation (TMS) has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions; even showing initial promise for PTSD. We propose to study this further in a randomized sham controlled trial of TMS for PTSD.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 18, 2022 |
Est. primary completion date | February 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Adult participants represent a typically developing nervous system as a more reliable target for this stage of research. 2. The presence of a PTSD diagnosis made by a physician will ensure participants are experiencing significant symptomatology and may benefit from treatment. 3. The cutoff score on the PCL-5 will ensure that participants are experiencing similar levels of symptoms to each other. 4. Need to have tried at least two types of treatment in the past Exclusion Criteria: 1. Significant past medical history including seizures, stroke, severe traumatic brain injury, or central nervous system cancers may interfere with our evaluation of treatment outcome and will be criteria for exclusion. 2. Metal in head/neck/eye is a contraindication to safety in the MRI scanner and TMS protocol. 3. Women who are pregnant will not be included in the study due to potential risk of seizure during TMS. To determine if a patient is pregnant we will ask when their last menstrual cycle occurred. If there is a possibility of pregnancy, we will ask the participant to follow-up with their family doctor to confirm. We will then ask the participant to provide a written note from their treating practitioner stating they are not pregnant. 4. Active suicidality 5. Wellbutrin or benzodiazepine intake of more than 200mg/day, or more than 15 mg of Zopiclone per day as these medications lower seizure threshold 6. Trauma experienced less than a year ago and/or trauma experienced only as a child 7. Drug and/or alcohol abuse within the last 3 months (diagnosed by Canadian guidelines) 8. Diagnosed schizophrenia, untreated bipolar disorder, or psychosis |
Country | Name | City | State |
---|---|---|---|
Canada | Foothill Medical Centre | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Defence Research and Development Canada |
Canada,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effect of rTMS on Quality of Life After Brain Injury survey (QOLIBRI), headaches, anxiety and depression in individuals with PTSD | To determine if quality of life (QOLIBRI), including headaches, anxiety, and depression also improve with the rTMS treatment in individuals suffering with PTSD | Change in QOLIBRI score at the pre-treatment appointment compared with 1 week, upon study completion, and 4 weeks post treatment. | |
Primary | Effect of 20-session rTMS Intervention to the DMPFC versus DLPFC on PCL Overall Score, Stratified by Verbal Memory Task Scores | To determine whether patients with PTSD_LVMS have a greater response to a 20-day low frequency rTMS treatment protocol of the right DMPFC compared to the DLPFC, and if patients with PTSD_NVMS respond better to a 20-day low frequency TMS treatment protocol of the right DLPFC compared to the DMPFC as measured by the clinician administered PTSD scale for DSM-5 (CAPS-5) in male and female participants (military personnel and civilians) at 4 weeks and 1 month post-treatment. | Change in PCL-5 score at pre-treatment appointment, compared with the score at 1 week, upon study completion, and 4 weeks post-rTMS treatment. | |
Secondary | Serum BDNF, Glutamate, Glutathione, and MR Spectroscopy pre and post rTMS intervention | To determine if serum brain derived neurotrophic factor (BDNF), glutamate, glutathione, and MR spectroscopy imaging will predict rTMS response in individuals with PTSD compared to those that do not respond to rTMS treatment. | Change in serum BDNF, glutamate, and glutathione at the pre-treatment appointment compared with 1 week into treatment and upon study completion. |
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