Trauma and Stressor Related DisordersPhase 2/3ETMS4StressNCT05835414
Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD)
A Phase 2/3 study testing Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS) in people with Trauma and Stressor Related Disorders, run by Marcia Bockbrader, MD PhD at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the safety, feasibility, and preliminary efficacy of EEG-enhanced transcranial magnetic stimulation (eTMS) as an adjunct to standard-of-care therapies for chronic trauma and stressor related disorders (TSRD) among US military veterans. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Trauma and Stressor Related Disorders
- What is being tested?
- Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 30 Jun 2025
- Phase
- Phase 2/3
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive identification as a Veteran per discharge paperwork (DD-214, DD-215, NGB-22, NGB-22A) and photo ID, or Veterans Health Administration Veteran Health Identification Card (VHIC)
- Presence of deployment-related stressful events (as defined by the Deployment Risk \& Resilience Inventory-2, DRRI-2)
- Trauma event(s) (defined on the Life Experiences Checklist for DSM-5, LEC-5)
- Presence of 6 months or more of 6 or more "moderate" or worse symptoms from any of the five categories associated with stress disorders as operationalized on the PTSD Checklist for DSM-5 (PCL-5; intrusion, altered mood and cognitions, dissociation, avoidance, and arousal).
- Informed consent for study participation, off label-eTMS, and data use
- Enrollment in addiction services, if meets standard addiction treatment criteria
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- Enrollment in opioid reduction services, if dependent on opioids and morphine equivalent daily dose exceeds 50 mg (50 morphine equivalent daily dose, MEDD)
- Agreement to limit daily alcoholic beverage consumption to no more than 2 servings
- Signed pain contract, if MEDD >= 80, per State of Ohio prescribing guidelines
Who cannot join
- Uncontrolled medical, psychological or neurological conditions including, but not limited to:
- Uncontrolled psychosis or mania
- Uncontrolled seizure disorder or EEG abnormalities that indicate risk of seizure, i.e., epileptiform discharges during the EEG recording
- Uncontrolled cardiac, pulmonary, or endocrine disorder (e.g., diabetes)
- Acute pain or illness
- Active, untreated addiction to prescription drugs, alcohol or illicit substances (not including cannabis or derivatives, which are available in many states under medical prescription or for recreational use)
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- Clinically significant medical condition or abnormality that in the Investigator's judgment might pose a potential safety risk to the subject or limit the interpretation of the trial results
- Pregnant, or female unwilling to use effective birth control during the course of the trial (unless cleared for participation by obstetrician/gynecologist)
- Absolute contraindications to TMS: Presence of aneurysm clips or coils, cochlear or ocular implant, cortical epidural stimulator, deep brain stimulator, pacemaker or defibrillator, retained intracranial metal foreign body (bullets, shrapnel - excluding titanium and oral implants), steel stents or shunts, active vagal nerve stimulator, ventriculoperitoneal (VP) shunt.
- Prior TMS treatment
- Unwilling or unable to adhere to the study treatment, data collection schedule, or study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
BEP Medical Group LLC
Columbus, Ohio, 43221
Practice Manager, 614-670-4000, admin@bepmedicalgroup.com
Marcia A Bockbrader, MD, PhD
About this study
Official title: Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS for Stress)
The goal of this clinical trial is to learn about the safety, feasibility, and preliminary efficacy of EEG-enhanced transcranial magnetic stimulation (eTMS) as an adjunct to standard-of-care therapies for chronic trauma and stressor related disorders (TSRD) among US military veterans.
The main questions the study aims to answer are:
Read more
- Is it safe to provide 30 sessions of eTMS for veterans with chronic TSRD?
- Is it feasible to provide 30 sessions of eTMS as an adjunct to standard-of-care therapies for veterans with chronic TSRD?
- Does health-related quality of life improve among veterans after 30 sessions of eTMS as an adjunct to standard-of-care therapies for chronic TSRD?
Participants will undergo 30 sessions of eTMS as an adjunct to standard-of-care therapies for veterans with chronic TSRD, weekly reassessment during treatment, and intermittent follow-up for 36 weeks post-enrollment.
- Conditions
- Trauma and Stressor Related Disorders
- Being tested
- Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)
- Keywords
- Transcranial Magnetic Stimulation, Chronic Trauma and Stressor Related Disorders, Veterans RAND 36-item health survey (VR-36), Health Related Quality of Life, EEG, Alpha Rhythms
- Medical subject headings
- Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)Device
Approximately 2000 pulses per session (x30 sessions) of midline prefrontal, repetitive transcranial magnetic stimulation at 50% or less of motor threshold, calibrated via EEG to a resonant alpha frequency of the participant, and given over approximately 12 minutes. Given as an adjunct to standard of care and integrative treatment for TSRD.
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive eTMS treatment (no delay) | Experimental | 6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment Receives: Device: Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with device-related serious adverse events
To address safety of the procedure, the study investigators will report number of participants (of 30 initial cohort) with expected, device-related serious adverse events (SAE's) or unexpected, device-related SAE's during treatment
Measured: 6 weeks
Rate of participants completing 80% of scheduled visits
To assess feasibility of the procedure, the study investigators will report the rate of participants (for initial cohort of 30) completing >= 80% of the 30 scheduled eTMS sessions
Measured: 6 weeks
Secondary outcomes (1)
Mean change in Veterans RAND 36-item health survey (VR-36) mental component scores (MCS)
To assess efficacy of the procedure to improve health related quality of life, the study investigators will report the mean change from baseline to week 6 in mental component score (MCS) on Veterans RAND 36-item health survey (VR-36) for participants (in initial cohort of 30) who completed >=80% of eTMS sessions
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start10 Apr 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma and Stressor Related DisordersStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a staged, open-label, Phase II/III safety, feasibility, and efficacy investigational device trial. A staged approach will be utilized to assess safety, feasibility, and preliminary efficacy with 30 participants with an interim analysis after data collection at 6 weeks. If safety benchmarks are passed, the study will proceed with Stage 2, in which an additional 270 participants will be enrolled using randomization to multiple baselines for efficacy analyses.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcia Bockbrader, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcia Bockbrader, MD PhD, BEP Medical Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835414
- Sponsor's protocol ID
- BEP-001
- Acronym
- ETMS4Stress
- Status last verified
- May 2023
- First submitted
- 18 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS for Stress)
- ClinicalTrials.gov ID
- NCT05835414
- Acronym / sponsor ID
- ETMS4Stress / BEP-001
- Conditions
- Trauma and Stressor Related Disorders
- Keywords
- Transcranial Magnetic Stimulation, Chronic Trauma and Stressor Related Disorders, Veterans RAND 36-item health survey (VR-36), Health Related Quality of Life, EEG, Alpha Rhythms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marcia Bockbrader, MD PhDUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 Apr 2023 (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.
The goal of this clinical trial is to learn about the safety, feasibility, and preliminary efficacy of EEG-enhanced transcranial magnetic stimulation (eTMS) as an adjunct to standard-of-care therapies for chronic trauma and stressor related disorders (TSRD) among US military veterans.
The main questions the study aims to answer are:
- Is it safe to provide 30 sessions of eTMS for veterans with chronic TSRD?
- Is it feasible to provide 30 sessions of eTMS as an adjunct to standard-of-care therapies for veterans with chronic TSRD?
- Does health-related quality of life improve among veterans after 30 sessions of eTMS as an adjunct to standard-of-care therapies for chronic TSRD?
Participants will undergo 30 sessions of eTMS as an adjunct to standard-of-care therapies for veterans with chronic TSRD, weekly reassessment during treatment, and intermittent follow-up for 36 weeks post-enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a staged, open-label, Phase II/III safety, feasibility, and efficacy investigational device trial. A staged approach will be utilized to assess safety, feasibility, and preliminary efficacy with 30 participants with an interim analysis after data collection at 6 weeks. If safety benchmarks are passed, the study will proceed with Stage 2, in which an additional 270 participants will be enrolled using randomization to multiple baselines for efficacy analyses.
| Arm | Type | Receives |
|---|---|---|
| Adjunctive eTMS treatment (no delay) | Experimental | Device: Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Positive identification as a Veteran per discharge paperwork (DD-214, DD-215, NGB-22, NGB-22A) and photo ID, or Veterans Health Administration Veteran Health Identification Card (VHIC)
- Presence of deployment-related stressful events (as defined by the Deployment Risk \& Resilience Inventory-2, DRRI-2)
- Trauma event(s) (defined on the Life Experiences Checklist for DSM-5, LEC-5)
- Presence of 6 months or more of 6 or more "moderate" or worse symptoms from any of the five categories associated with stress disorders as operationalized on the PTSD Checklist for DSM-5 (PCL-5; intrusion, altered mood and cognitions, dissociation, avoidance, and arousal).
- Informed consent for study participation, off label-eTMS, and data use
Key exclusion criteria (11 listed)
- Uncontrolled medical, psychological or neurological conditions including, but not limited to:
- Uncontrolled psychosis or mania
- Uncontrolled seizure disorder or EEG abnormalities that indicate risk of seizure, i.e., epileptiform discharges during the EEG recording
- Uncontrolled cardiac, pulmonary, or endocrine disorder (e.g., diabetes)
- Acute pain or illness
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 |
|---|---|---|
| Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)Approximately 2000 pulses per session (x30 sessions) of midline prefrontal, repetitive transcranial magnetic stimulation at 50% or less of motor threshold, calibrated via EEG to a resonant alpha frequency of the participant, and given over approximately 12 minutes. Given as an adjunct to standard of care and integrative treatment for TSRD. | Device | Adjunctive eTMS treatment (no delay) |
Primary outcome
Number of participants with device-related serious adverse events
Time frame: 6 weeks
To address safety of the procedure, the study investigators will report number of participants (of 30 initial cohort) with expected, device-related serious adverse events (SAE's) or unexpected, device-related SAE's during treatment
Rate of participants completing 80% of scheduled visits
Time frame: 6 weeks
To assess feasibility of the procedure, the study investigators will report the rate of participants (for initial cohort of 30) completing >= 80% of the 30 scheduled eTMS sessions
1 secondary outcome
Mean change in Veterans RAND 36-item health survey (VR-36) mental component scores (MCS)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS) in people with Trauma and Stressor Related Disorders, run by Marcia Bockbrader, MD PhD at 1 site in United States.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcia A Bockbrader, MD, PhD (614-670-4000, dr.marcie@bepmedicalgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with device-related serious adverse events (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.