Electroencephalogram (EEG) Enhanced Transcranial Magnetic... | NCT05835414

NCT05835414

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adjunctive eTMS treatment (no delay)	Experimental	6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment	Device: Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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 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)
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

Name	Role	Phone	Extension	Email
Marcia A Bockbrader, MD, PhD	Contact	614-670-4000		dr.marcie@bepmedicalgroup.com
Neil B Austin	Contact	614-670-4000		neil@bepmedicalgroup.com

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics