Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD)
NCT ID: NCT05835414
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2023-04-10
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adjunctive eTMS treatment (no delay)
6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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)
* 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
22 Years
ALL
No
Sponsors
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Marcia Bockbrader, MD PhD
OTHER
Responsible Party
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Marcia Bockbrader, MD PhD
Principal Investigator
Locations
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BEP Medical Group LLC
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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BEP-001
Identifier Type: -
Identifier Source: org_study_id
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