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eTMS for Stress-Related Disorders (ETMS4Stress Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Marcia Bockbrader, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
ETMS4Stress Trial Summary
This trial will assess the safety, feasibility and efficacy of eTMS for veterans with chronic TSRD.
Who is the study for?
This trial is for US military veterans with chronic trauma and stressor-related disorders who have experienced deployment-related stressful events. They must be enrolled in addiction or opioid reduction services if applicable, agree to limit alcohol intake, and not exceed a certain daily dose of opioids. Those with uncontrolled medical conditions, active untreated addictions (except cannabis), or contraindications to TMS like metal implants are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of EEG-enhanced transcranial magnetic stimulation (eTMS) as an additional treatment alongside standard care for veterans' chronic trauma disorders. It involves 30 sessions of eTMS over several weeks, with regular reassessments and follow-ups extending up to 36 weeks post-enrollment.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures. However, since this trial aims to assess safety among other factors, all possible side effects will be closely monitored throughout the study.
ETMS4Stress Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with device-related serious adverse events
Rate of participants completing 80% of scheduled visits
Secondary outcome measures
Mean change in Veterans RAND 36-item health survey (VR-36) mental component scores (MCS)
ETMS4Stress Trial Design
1Treatment groups
Experimental Treatment
Group I: Adjunctive eTMS treatment (no delay)Experimental Treatment1 Intervention
6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment
Find a Location
Who is running the clinical trial?
Ohio Department of Mental Health and Addiction ServicesUNKNOWN
Marcia Bockbrader, MD PhDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have signed a pain management agreement as required for my medication dosage.I have experienced significant stress symptoms for 6 months or more.
Research Study Groups:
This trial has the following groups:- Group 1: Adjunctive eTMS treatment (no delay)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are enrolled in the investigation?
"Affirmative. According to clinicaltrials.gov, the study is presently soliciting participants; it was initially posted on April 10th 2023 and modified most recently on April 18th of the same year. 30 individuals are needed at one medical site for this trial."
Answered by AI
Would I be able to enroll in this study today?
"According to clinicaltrials.gov, this trial is presently recruiting individuals. The initial listing was posted on April 10th 2023 and was recently amended on April 18th 2023."
Answered by AI
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