RECRUITING

Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD)

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Conditions

Trauma and Stressor Related DisordersTranscranial Magnetic StimulationChronic Trauma and Stressor Related DisordersVeterans RAND 36-item health survey (VR-36)Health Related Quality of LifeEEGAlpha Rhythms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS for Stress)

Quick Facts

Study Start:2023-04-10
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05835414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Presence of deployment-related stressful events (as defined by the Deployment Risk \& Resilience Inventory-2, DRRI-2)
  3. * Trauma event(s) (defined on the Life Experiences Checklist for DSM-5, LEC-5)
  4. * 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).
  5. * Informed consent for study participation, off label-eTMS, and data use
  6. * Enrollment in addiction services, if meets standard addiction treatment criteria
  7. * Enrollment in opioid reduction services, if dependent on opioids and morphine equivalent daily dose exceeds 50 mg (50 morphine equivalent daily dose, MEDD)
  8. * Agreement to limit daily alcoholic beverage consumption to no more than 2 servings
  9. * Signed pain contract, if MEDD \>= 80, per State of Ohio prescribing guidelines
  1. * Uncontrolled medical, psychological or neurological conditions including, but not limited to:
  2. * Uncontrolled psychosis or mania
  3. * Uncontrolled seizure disorder or EEG abnormalities that indicate risk of seizure, i.e., epileptiform discharges during the EEG recording
  4. * Uncontrolled cardiac, pulmonary, or endocrine disorder (e.g., diabetes)
  5. * Acute pain or illness
  6. * 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)
  7. * 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
  8. * Pregnant, or female unwilling to use effective birth control during the course of the trial (unless cleared for participation by obstetrician/gynecologist)
  9. * 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.
  10. * Prior TMS treatment
  11. * Unwilling or unable to adhere to the study treatment, data collection schedule, or study procedures

Contacts and Locations

Study Contact

Marcia A Bockbrader, MD, PhD
CONTACT
614-670-4000
dr.marcie@bepmedicalgroup.com
Neil B Austin
CONTACT
614-670-4000
neil@bepmedicalgroup.com

Study Locations (Sites)

BEP Medical Group LLC
Columbus, Ohio, 43221
United States

Collaborators and Investigators

Sponsor: Marcia Bockbrader, MD PhD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-10
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-04-10
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Trauma and Stressor Related Disorders