CompletedNot Applicable

Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Post-Traumatic Stress Disorder

United States158 participantsStarted 2022-04-04

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of individualized, Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Post-Traumatic Stress Disorder

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Willing and able to consent to participate in the study
✓. Age 18 - 65 years
✓. Diagnosis of PTSD according to DSM-V criteria via CAPS-5
✓. Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms persisting for a minimum of 6 months prior to the Screening Visit
✓. Minimum PCL-5 score of 30

Exclusion criteria

✕. Index trauma occurred before the age of 16 years
✕. History of open skull injury
✕. History of a neurological disorder including, but not limited to:
✕. History of cerebrovascular accident
✕. History of cerebral aneurysm
✕. EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing, or ictal spikes, during the EEG recording
✕. Inability to calculate the EEG intrinsic alpha frequency at Screening
✕. Participation in any interventional research protocol within 3 months prior to the Screening Visit

What they're measuring

Change in PTSD Symptoms

Timeframe: Five weeks

Trial details

NCT IDNCT02990793

SponsorWave Neuroscience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-18

View on ClinicalTrials.gov More PostTraumatic Stress Disorder trials