Pathophysiological Understanding and Treatment of PTSD: an rTMS Approach
NCT ID: NCT03840369
Last Updated: 2022-11-04
Study Results
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Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2020-06-01
2022-03-18
Brief Summary
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Detailed Description
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A recent meta-analysis on TMS and PTSD found that no study has examined the difference between genders, and recommended that further studies with larger sample sizes, equal male and female participants, and more stringent study designs were required. Our study is novel and seeks to bridge the gap from research to clinical care by completing a study investigating repetitive TMS (rTMS) treatment for PTSD that recruits a large sample size, uses a randomized controlled clinical trial with a sham lead-in, and follows a stringent TMS protocol with equal sex participants.
Not all individuals with PTSD respond to TMS treatment, and no study to date has explored what biomarkers may predict TMS responders in the PTSD population. Previous studies propose glutamate, BDNF and glutamatergic changes on MR spectroscopy may be altered in other mental health illnesses, which suggests they may be useful biomarkers of TMS response in PTSD. Therefore, this study will be the first of its kind to develop predictive biomarkers of response by sampling serum BDNF, glutamate, and glutamatergic changes in MR spectroscopy pre- and post rTMS treatment, in patients with PTSD that respond to TMS compared to those that do not.
Recent studies have shown single-pulse TMS is beneficial for some individuals with chronic PTSD, and emerging evidence suggests there are specific phenotypes within PTSD that may require different TMS protocols. A recent study by Etkin et al. explored whether there were multiple phenotypes within chronic PTSD that would explain treatment responses. They found individuals with PTSD that scored significantly lower on verbal memory tasks (LVMS) (list repetition) had significantly impaired functional connectivity in the brain's ventral attention network (VAN) compared to patients with PTSD that had normal scores (NVMS). This suggests there may be a subgroup of patients with PTSD that would respond better to TMS in the right dorsal medial prefrontal cortex (DMPFC) (corresponding to the VAN) than to the right dorsal lateral prefrontal cortex (DLPFC).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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rTMS to the Right Dorsolateral Prefrontal Cortex
Patients will engage in a one-week placebo control lead-in (5 treatments) and then a four-week treatment protocol (20 treatments) to the right Dorsolateral Prefrontal Cortex (DLPFC). The right DLPFC will be located with MR brain scans and the BrainSight TMS neuronavigation software. The intensity of the rTMS will be 100-120% of resting motor threshold amplitude, 1500 pulses applied consistently with a frequency of 1 Hz.
Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal Cortex
Transcranial magnetic stimulation (TMS) works by delivering a magnetic pulse to a focal brain region. TMS has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions. Repetitive TMS (rTMS) delivers pulses at a set time interval in order to modulate neural activity in that region.
Sham Repetitive Transcranial Magnetic Stimulation
The sham TMS coil will make a similar sound to the real rTMS coil, but will not deliver a magnetic pulse. This is a no-treatment device.
rTMS to the Right Dorsomedial Prefrontal Cortex
Patients will engage in a one-week placebo control lead-in (5 treatments) and then a four-week treatment protocol (20 treatments) to the right Dorsomedial Prefrontal Cortex (DMPFC). The right DMPFC will be located with MR brain scans and the BrainSight TMS neuronavigation software. The intensity of the rTMS will be 100-120% of resting motor threshold amplitude, 1500 pulses applied consistently with a frequency of 1 Hz.
Sham Repetitive Transcranial Magnetic Stimulation
The sham TMS coil will make a similar sound to the real rTMS coil, but will not deliver a magnetic pulse. This is a no-treatment device.
Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal Cortex
Transcranial magnetic stimulation (TMS) works by delivering a magnetic pulse to a focal brain region. TMS has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions. Repetitive TMS (rTMS) delivers pulses at a set time interval in order to modulate neural activity in that region.
Interventions
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Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal Cortex
Transcranial magnetic stimulation (TMS) works by delivering a magnetic pulse to a focal brain region. TMS has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions. Repetitive TMS (rTMS) delivers pulses at a set time interval in order to modulate neural activity in that region.
Sham Repetitive Transcranial Magnetic Stimulation
The sham TMS coil will make a similar sound to the real rTMS coil, but will not deliver a magnetic pulse. This is a no-treatment device.
Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal Cortex
Transcranial magnetic stimulation (TMS) works by delivering a magnetic pulse to a focal brain region. TMS has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions. Repetitive TMS (rTMS) delivers pulses at a set time interval in order to modulate neural activity in that region.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Defence Research and Development Canada
INDUSTRY
University of Calgary
OTHER
Responsible Party
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Locations
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Foothill Medical Centre
Calgary, Alberta, Canada
Countries
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References
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Related Links
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National Center for PTSD
Other Identifiers
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REB18-1976
Identifier Type: -
Identifier Source: org_study_id
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