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Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS4Stress)

Primary Purpose

Trauma and Stressor Related Disorders

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)
Sponsored by
Marcia Bockbrader, MD PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma and Stressor Related Disorders focused on measuring 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

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BEP Medical Group LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adjunctive eTMS treatment (no delay)

Arm Description

6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2023
Last Updated
May 3, 2023
Sponsor
Marcia Bockbrader, MD PhD
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1. Study Identification

Unique Protocol Identification Number
NCT05835414
Brief Title
Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD)
Acronym
ETMS4Stress
Official Title
Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS for Stress)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marcia Bockbrader, MD PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjunctive eTMS treatment (no delay)
Arm Type
Experimental
Arm Description
6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment
Intervention Type
Device
Intervention Name(s)
Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with device-related serious adverse events
Description
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
Time Frame
6 weeks
Title
Rate of participants completing 80% of scheduled visits
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Mean change in Veterans RAND 36-item health survey (VR-36) mental component scores (MCS)
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcia A Bockbrader, MD, PhD
Phone
614-670-4000
Email
dr.marcie@bepmedicalgroup.com
First Name & Middle Initial & Last Name or Official Title & Degree
Neil B Austin
Phone
614-670-4000
Email
neil@bepmedicalgroup.com
Facility Information:
Facility Name
BEP Medical Group LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Practice Manager
Phone
614-670-4000
Email
admin@bepmedicalgroup.com
First Name & Middle Initial & Last Name & Degree
Marcia A Bockbrader, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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