eTMS for Veterans and First Responders With PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS).
- Who it may be relevant to
- Registry conditions: Post Traumatic Stress Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder (PTSD)
Overview
A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.
Detailed description
Veterans and first responders diagnosed with PTSD will be studied to evaluate safety and efficacy of an EEG personalized TMS paradigm. All participants will undergo 2 days of extensive testing prior to eTMS application and 2 days of testing after. Testing will include MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study.
Interventions
- Device Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)
EEG is utilized to determine a personalized frequency to then apply TMS to the frontal lobe.
Primary outcome measures
- Adverse Events [Time frame: Up to 7 weeks]
- Report of Symptoms [Time frame: Up to 7 weeks]
Secondary outcome measures (4)
- PCL-5 [Time frame: Up to 7 weeks]
- fMRI [Time frame: 1 session 1 week pre treatment and 1 session 1 week post treatment]
- OPM [Time frame: 1 session 1 week pre treatment and 1 session 1 week post treatment]
- EEG [Time frame: Up to 7 sessions collected over 7 weeks.]
Eligibility criteria
Inclusion criteria
- Veteran or first responder
- diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above
Exclusion criteria
- Claustrophobia
- Contraindications to MRI
- Pregnant
- Uncontrolled medical, psychological, or neurological conditions
- Unable to calculate EEG alpha frequency
- History of ECT or rTMS
- History of intracranial lesion or increased intracranial pressure
- History of stroke
- History of other neurologic conditions
- Family history of epilepsy
- Personal history of epilepsy
- certain medications
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Fralin Biomedical Research Institute — Roanoke
Identifiers
NCT: NCT06294106 · 24-212