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

Exclusion Criteria

• •1. Index trauma occurred before the age of 16 years
• •2. History of open skull injury
• •3. History of a neurological disorder including, but not limited to:
• •* Seizure disorder
• •* Any condition likely to be associated with increased intracranial pressure
• •* Space occupying brain lesion
• •4. History of cerebrovascular accident
• •5. History of cerebral aneurysm
• •6. EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing, or ictal spikes, during the EEG recording
• •7. Inability to calculate the EEG intrinsic alpha frequency at Screening
• •8. Participation in any interventional research protocol within 3 months prior to the Screening Visit
• •9. History of any type of ECT, rTMS, or MeRT treatment
• •10. Treated within 30 days of the Screening Visit with any antipsychotic medication
• •11. Treated within 30 days of the Screening Visit with any benzodiazepine or anticonvulsant medications
• •12. Current treatment with any restricted concomitant medication (i.e., NDRI, SSRI, SNRI, or QBDZ) that has not been stable for the preceding 60 days at the time of the Screening Visit
• •13. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within the head, excluding the mouth, or on the head, that cannot be safely removed
• •14. Biomedical devices, including those not in or on the head, that are either implanted or not safe to remove, that may be affected by the magnetic field of the stimulator (e.g., cardiac pacemaker, cardioverter defibrillator (ICD), or medication dispensing device)
• •15. Clinically significant medical illness or condition, including, but not limited to, any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunction, or chronic excessive alcohol consumption, that in the Investigator's judgment might pose a potential safety risk to the participant or limit the interpretation of trial results
• •16. Pregnant, or female unwilling to use effective birth control during the course of the trial
• •17. Plan to move away from the area, or knowledge that there will be an absence from the area, within 80 days following the Screening Visit (inclusive)
• •19. Clinically significant psychopathology, including, but not limited to, schizophrenia or bipolar disorder, or other psychiatric disorder that in the Investigator's judgment might pose a potential safety risk to the participant, or limit the interpretation of trial results
• •20. An elevated risk of suicide or violence to others
• •21. Current psychotherapeutic treatment, expected to continue throughout the trial, that was begun in the preceding 60 days at the time of the Screening Visit