Personalized TMS for Post-Traumatic Stress Disorder

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byBill Phillips, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wave Neuroscience

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a randomized, sham controlled study of the Electroencephalogram (EEG) based Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 110 participants who are United States Military veterans or first responders (e.g., firefighters, police, paramedics, etc.). The Study includes an EEG recording in order to determine the optimal treatment parameters for the eTMS system, followed by 15 in-office visits that take place over 21-28 total days. Two eTMS treatment sessions are administered during each office visit.

Eligibility Criteria

This trial is for U.S. Military veterans or first responders aged 22-65 with PTSD diagnosed by DSM-5 criteria, symptoms lasting at least 6 months, and a certain score on the PCL-5 scale. It's not for those who've had ECT/rTMS, have uncontrolled health conditions, are pregnant without birth control use, have metal in their head, history of seizures or epilepsy (or family history), current involvement in other trials, or high risk of suicide/violence.

Inclusion Criteria

Willing and able to consent to participate in the study via signed Informed Consent

I am between 22 and 65 years old.

I have been diagnosed with PTSD by a professional.

+3 more

Exclusion Criteria

I have undergone ECT or rTMS therapy.

I have a health condition that is not well-managed.

I am not pregnant and willing to use birth control during the trial.

+7 more

Participant Groups

The study tests EEG-based personalized TMS against a sham treatment to manage PTSD symptoms. Participants undergo an initial EEG to tailor the eTMS system settings followed by fifteen sessions over three to four weeks where two treatments are given per office visit.

2Treatment groups

Active Control

Placebo Group

Group I: Active eTMS treatmentActive Control1 Intervention

15 treatment days of EEG-based personalized TMS over a maximum of 28 days. Two sessions per treatment day. Each session consists of TMS treatment at 80% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.

Group II: Sham eTMS TreatmentPlacebo Group1 Intervention

15 treatment days of sham EEG-based personalized TMS over a maximum of 28 days. Two sessions per treatment day. Each session consists of sham TMS treatment. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.