Stress Disorders, Post-TraumaticPTSDNCT03840369
Pathophysiological Understanding and Treatment of PTSD: an rTMS Approach
A study testing Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal Cortex and Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal Cortex in people with Stress Disorders, Post-Traumatic and Brain Injuries, run by University of Calgary at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Brain Injuries, Transcranial Magnetic Stimulation
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal Cortex and Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal Cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2020to 18 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants represent a typically developing nervous system as a more reliable target for this stage of research.
- The presence of a PTSD diagnosis made by a physician will ensure participants are experiencing significant symptomatology and may benefit from treatment.
- The cutoff score on the PCL-5 will ensure that participants are experiencing similar levels of symptoms to each other.
- Need to have tried at least two types of treatment in the past
Who cannot join
- 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.
- Metal in head/neck/eye is a contraindication to safety in the MRI scanner and TMS protocol.
- 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.
- Active suicidality
- Wellbutrin or benzodiazepine intake of more than 200mg/day, or more than 15 mg of Zopiclone per day as these medications lower seizure threshold
- Trauma experienced less than a year ago and/or trauma experienced only as a child
- Drug and/or alcohol abuse within the last 3 months (diagnosed by Canadian guidelines)
- Diagnosed schizophrenia, untreated bipolar disorder, or psychosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In Canada, the prevalence of PTSD is approximately 12%, similar to Canadian military personnel. However, a 2002 study of members of Canadian Armed Forces found there was a striking positive correlation between the number of missions taken by the regular/reserve force and increase risk of developing PTSD, suggesting a dire need for further treatment options. Transcranial magnetic stimulation (TMS), a neuromodulation technique applied to the brain, has been studied as a treatment that has the potential to improve symptoms in a variety of neurological/mental health conditions. TMS is a safe and non-invasive technique that applies an electrical current to the brain to induce neuronal depolarization, changing regional brain function with the goal of improving neurological/psychiatric symptoms. Although multiple studies using TMS have suggested it as an efficacious treatment option for PTSD, clear knowledge gaps exist that prevent it from becoming evidence-based clinical care.
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
- Stress Disorders, Post-Traumatic, Brain Injuries, Transcranial Magnetic Stimulation, Magnetic Resonance Spectroscopy, Biomarkers, Depression, Anxiety
- Being tested
- Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal Cortex, Sham Repetitive Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal Cortex
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal CortexDevice
Also called rTMS to DLPFC
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 StimulationDevice
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 CortexDevice
Also called rTMS to DMPFC
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.
| Study group | Role | What they receive |
|---|---|---|
| rTMS to the Right Dorsolateral Prefrontal Cortex | Experimental | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal Cortex; Device: Sham Repetitive Transcranial Magnetic Stimulation |
| rTMS to the Right Dorsomedial Prefrontal Cortex | Experimental | 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. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation; Device: Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal Cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: Change in serum BDNF, glutamate, and glutathione at the pre-treatment appointment compared with 1 week into treatment and upon study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jun 2020
- Primary completion18 Feb 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Treatment of the right dorsolateral prefrontal cortex Group 2: Treatment of the right dorsomedial prefrontal cortex
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Defence Research and Development Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840369
- Sponsor's protocol ID
- REB18-1976
- Acronym
- PTSD
- Status last verified
- May 2022
- First submitted
- 7 Feb 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pohar R, Farrah K. Repetitive Transcranial Magnetic Stimulation for Patients with Depression: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines - An Update [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jun 28. Available from http://www.ncbi.nlm.nih.gov/books/NBK545105/
PubMed 31433608Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1.
PubMed 12849236Vucic S, Kiernan MC. Transcranial Magnetic Stimulation for the Assessment of Neurodegenerative Disease. Neurotherapeutics. 2017 Jan;14(1):91-106. doi: 10.1007/s13311-016-0487-6.
PubMed 27830492Enokibara M, Trevizol A, Shiozawa P, Cordeiro Q. Establishing an effective TMS protocol for craving in substance addiction: Is it possible? Am J Addict. 2016 Jan;25(1):28-30. doi: 10.1111/ajad.12309. Epub 2015 Dec 21.
PubMed 26692110Lee JC, Blumberger DM, Fitzgerald PB, Daskalakis ZJ, Levinson AJ. The role of transcranial magnetic stimulation in treatment-resistant depression: a review. Curr Pharm Des. 2012;18(36):5846-52. doi: 10.2174/138161212803523644.
PubMed 22681165Kozel FA, Motes MA, Didehbani N, DeLaRosa B, Bass C, Schraufnagel CD, Jones P, Morgan CR, Spence JS, Kraut MA, Hart J Jr. Repetitive TMS to augment cognitive processing therapy in combat veterans of recent conflicts with PTSD: A randomized clinical trial. J Affect Disord. 2018 Mar 15;229:506-514. doi: 10.1016/j.jad.2017.12.046. Epub 2017 Dec 28.
PubMed 29351885Yan T, Xie Q, Zheng Z, Zou K, Wang L. Different frequency repetitive transcranial magnetic stimulation (rTMS) for posttraumatic stress disorder (PTSD): A systematic review and meta-analysis. J Psychiatr Res. 2017 Jun;89:125-135. doi: 10.1016/j.jpsychires.2017.02.021. Epub 2017 Feb 27.
PubMed 28278422Fryml LD, Sahlem G, Fox J, Short EB. The role of rTMS for patients with severe PTSD and depression. Evid Based Ment Health. 2018 Feb;21(1):39-40. doi: 10.1136/eb-2017-102819. Epub 2018 Jan 5. No abstract available.
PubMed 29305359Osuch EA, Benson BE, Luckenbaugh DA, Geraci M, Post RM, McCann U. Repetitive TMS combined with exposure therapy for PTSD: a preliminary study. J Anxiety Disord. 2009 Jan;23(1):54-9. doi: 10.1016/j.janxdis.2008.03.015. Epub 2008 Mar 28.
PubMed 18455908Wang HN, Bai YH, Chen YC, Zhang RG, Wang HH, Zhang YH, Gan JL, Peng ZW, Tan QR. Repetitive transcranial magnetic stimulation ameliorates anxiety-like behavior and impaired sensorimotor gating in a rat model of post-traumatic stress disorder. PLoS One. 2015 Feb 6;10(2):e0117189. doi: 10.1371/journal.pone.0117189. eCollection 2015.
PubMed 25659132Philip NS, Ridout SJ, Albright SE, Sanchez G, Carpenter LL. 5-Hz Transcranial Magnetic Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depression. J Trauma Stress. 2016 Feb;29(1):93-6. doi: 10.1002/jts.22065. Epub 2016 Jan 7.
PubMed 26748883Pradhan B, Kluewer D'Amico J, Makani R, Parikh T. Nonconventional interventions for chronic post-traumatic stress disorder: Ketamine, repetitive trans-cranial magnetic stimulation (rTMS), and alternative approaches. J Trauma Dissociation. 2016;17(1):35-54. doi: 10.1080/15299732.2015.1046101. Epub 2015 Jul 10.
PubMed 26162001Watts BV, Landon B, Groft A, Young-Xu Y. A sham controlled study of repetitive transcranial magnetic stimulation for posttraumatic stress disorder. Brain Stimul. 2012 Jan;5(1):38-43. doi: 10.1016/j.brs.2011.02.002. Epub 2011 Mar 3.
PubMed 22264669Nam DH, Pae CU, Chae JH. Low-frequency, Repetitive Transcranial Magnetic Stimulation for the Treatment of Patients with Posttraumatic Stress Disorder: a Double-blind, Sham-controlled Study. Clin Psychopharmacol Neurosci. 2013 Aug;11(2):96-102. doi: 10.9758/cpn.2013.11.2.96. Epub 2013 Aug 26.
PubMed 24023554Oznur T, Akarsu S, Celik C, Bolu A, Ozdemir B, Akcay BD, Ozselek S, Bozkurt A, Ozmenler KN. Is transcranial magnetic stimulation effective in treatment-resistant combat related posttraumatic stress disorder? Neurosciences (Riyadh). 2014 Jan;19(1):29-32.
PubMed 24419446
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Understanding and Treatment of PTSD: an rTMS Approach
- ClinicalTrials.gov ID
- NCT03840369
- Acronym / sponsor ID
- PTSD / REB18-1976
- Conditions
- Stress Disorders, Post-Traumatic, Brain Injuries, Transcranial Magnetic Stimulation, Magnetic Resonance Spectroscopy, Biomarkers, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Defence Research and Development Canada
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In Canada, the prevalence of PTSD is approximately 12%, similar to Canadian military personnel. However, a 2002 study of members of Canadian Armed Forces found there was a striking positive correlation between the number of missions taken by the regular/reserve force and increase risk of developing PTSD, suggesting a dire need for further treatment options. Transcranial magnetic stimulation (TMS), a neuromodulation technique applied to the brain, has been studied as a treatment that has the potential to improve symptoms in a variety of neurological/mental health conditions. TMS is a safe and non-invasive technique that applies an electrical current to the brain to induce neuronal depolarization, changing regional brain function with the goal of improving neurological/psychiatric symptoms. Although multiple studies using TMS have suggested it as an efficacious treatment option for PTSD, clear knowledge gaps exist that prevent it from becoming evidence-based clinical care.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Group 1: Treatment of the right dorsolateral prefrontal cortex Group 2: Treatment of the right dorsomedial prefrontal cortex
| Arm | Type | Receives |
|---|---|---|
| rTMS to the Right Dorsolateral Prefrontal Cortex | Experimental | Device: Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal Cortex, Device: Sham Repetitive Transcranial Magnetic StimulationPatients 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. |
| rTMS to the Right Dorsomedial Prefrontal Cortex | Experimental | Device: Sham Repetitive Transcranial Magnetic Stimulation, Device: Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal CortexPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult participants represent a typically developing nervous system as a more reliable target for this stage of research.
- The presence of a PTSD diagnosis made by a physician will ensure participants are experiencing significant symptomatology and may benefit from treatment.
- The cutoff score on the PCL-5 will ensure that participants are experiencing similar levels of symptoms to each other.
- Need to have tried at least two types of treatment in the past
Key exclusion criteria (8 listed)
- 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.
- Metal in head/neck/eye is a contraindication to safety in the MRI scanner and TMS protocol.
- 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.
- Active suicidality
- Wellbutrin or benzodiazepine intake of more than 200mg/day, or more than 15 mg of Zopiclone per day as these medications lower seizure threshold
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal CortexAlso: rTMS to DLPFCTranscranial 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. | Device | rTMS to the Right Dorsolateral Prefrontal Cortex |
| Sham Repetitive Transcranial Magnetic StimulationThe 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. | Device | rTMS to the Right Dorsolateral Prefrontal Cortex, rTMS to the Right Dorsomedial Prefrontal Cortex |
| Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal CortexAlso: rTMS to DMPFCTranscranial 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. | Device | rTMS to the Right Dorsomedial Prefrontal Cortex |
Primary outcome
Effect of 20-session rTMS Intervention to the DMPFC versus DLPFC on PCL Overall Score, Stratified by Verbal Memory Task Scores
Time frame: 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.
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.
1 secondary outcome
Serum BDNF, Glutamate, Glutathione, and MR Spectroscopy pre and post rTMS intervention
Time frame: Change in serum BDNF, glutamate, and glutathione at the pre-treatment appointment compared with 1 week into treatment and upon study completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 31433608Pohar R, Farrah K. Repetitive Transcranial Magnetic Stimulation for Patients with Depression: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines - An Update [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jun 28. Available from http://www.ncbi.nlm.nih.gov/books/NBK545105/
- Background: PubMed 12849236Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1.
- Background: PubMed 27830492Vucic S, Kiernan MC. Transcranial Magnetic Stimulation for the Assessment of Neurodegenerative Disease. Neurotherapeutics. 2017 Jan;14(1):91-106. doi: 10.1007/s13311-016-0487-6.
- Background: PubMed 26692110Enokibara M, Trevizol A, Shiozawa P, Cordeiro Q. Establishing an effective TMS protocol for craving in substance addiction: Is it possible? Am J Addict. 2016 Jan;25(1):28-30. doi: 10.1111/ajad.12309. Epub 2015 Dec 21.
- Background: PubMed 22681165Lee JC, Blumberger DM, Fitzgerald PB, Daskalakis ZJ, Levinson AJ. The role of transcranial magnetic stimulation in treatment-resistant depression: a review. Curr Pharm Des. 2012;18(36):5846-52. doi: 10.2174/138161212803523644.
- Background: PubMed 29351885Kozel FA, Motes MA, Didehbani N, DeLaRosa B, Bass C, Schraufnagel CD, Jones P, Morgan CR, Spence JS, Kraut MA, Hart J Jr. Repetitive TMS to augment cognitive processing therapy in combat veterans of recent conflicts with PTSD: A randomized clinical trial. J Affect Disord. 2018 Mar 15;229:506-514. doi: 10.1016/j.jad.2017.12.046. Epub 2017 Dec 28.
- Background: PubMed 28278422Yan T, Xie Q, Zheng Z, Zou K, Wang L. Different frequency repetitive transcranial magnetic stimulation (rTMS) for posttraumatic stress disorder (PTSD): A systematic review and meta-analysis. J Psychiatr Res. 2017 Jun;89:125-135. doi: 10.1016/j.jpsychires.2017.02.021. Epub 2017 Feb 27.
- Background: PubMed 29305359Fryml LD, Sahlem G, Fox J, Short EB. The role of rTMS for patients with severe PTSD and depression. Evid Based Ment Health. 2018 Feb;21(1):39-40. doi: 10.1136/eb-2017-102819. Epub 2018 Jan 5. No abstract available.
- Background: PubMed 18455908Osuch EA, Benson BE, Luckenbaugh DA, Geraci M, Post RM, McCann U. Repetitive TMS combined with exposure therapy for PTSD: a preliminary study. J Anxiety Disord. 2009 Jan;23(1):54-9. doi: 10.1016/j.janxdis.2008.03.015. Epub 2008 Mar 28.
- Background: PubMed 25659132Wang HN, Bai YH, Chen YC, Zhang RG, Wang HH, Zhang YH, Gan JL, Peng ZW, Tan QR. Repetitive transcranial magnetic stimulation ameliorates anxiety-like behavior and impaired sensorimotor gating in a rat model of post-traumatic stress disorder. PLoS One. 2015 Feb 6;10(2):e0117189. doi: 10.1371/journal.pone.0117189. eCollection 2015.
- Background: PubMed 26748883Philip NS, Ridout SJ, Albright SE, Sanchez G, Carpenter LL. 5-Hz Transcranial Magnetic Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depression. J Trauma Stress. 2016 Feb;29(1):93-6. doi: 10.1002/jts.22065. Epub 2016 Jan 7.
- Background: PubMed 26162001Pradhan B, Kluewer D'Amico J, Makani R, Parikh T. Nonconventional interventions for chronic post-traumatic stress disorder: Ketamine, repetitive trans-cranial magnetic stimulation (rTMS), and alternative approaches. J Trauma Dissociation. 2016;17(1):35-54. doi: 10.1080/15299732.2015.1046101. Epub 2015 Jul 10.
- National Center for PTSDLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal Cortex and Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal Cortex in people with Stress Disorders, Post-Traumatic and Brain Injuries, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of 20-session rTMS Intervention to the DMPFC versus DLPFC on PCL Overall Score, Stratified by Verbal Memory Task Scores (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03840369, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.