eTMS for Veterans and First Responders With PTSD
ConditionPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Polytechnic Institute and State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Veteran or first responder
diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above
Disqualifiers
Claustrophobia
Contraindications to MRI
Pregnant
Uncontrolled medical, psychological, or neurological conditions
Trial design
Design model
Parallel
Treatments tested in this trial
Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)
DeviceEEG is utilized to determine a personalized frequency to then apply TMS to the frontal lobe.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: eTMSExperimental treatment 1 intervention
Group B: eTMS shamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events
Adverse event reports (or lack-of) will determine device safety
Time frame
Up to 7 weeks2
Report of Symptoms
Symptom questionnaire to be completed before and after all study procedures to determine feasibility in this patient population. Various symptoms will be rated on a likert scale from absent to severe.
Time frame
Up to 7 weeksSecondary outcomes
1
PCL-5
Completion of the PTSD symptom questionnaire. Scores range from 0-80, with a PTSD cutoff score of 31.
Time frame
Up to 7 weeks2
fMRI
Functional MRI signals including BOLD signals collected at rest and during basic tasks to assess neuropathways of activation
Time frame
1 session 1 week pre treatment and 1 session 1 week post treatment3
OPM
Optically Pumped Magnetometry signals collected at rest and during basic tasks to assess neuropathways of activation
Time frame
1 session 1 week pre treatment and 1 session 1 week post treatment4
EEG
Electroencephalography recordings at rest and during a stress task. Specifically analyzing the P300.
Time frame
Up to 7 sessions collected over 7 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Polytechnic Institute and State University
Lead sponsor
Wave Neuroscience
Collaborator
Source ClinicalTrials.gov