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

Launched by WAVE NEUROSCIENCE · Dec 8, 2016

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Magnetic e-Resonance Therapy (MeRT) for people with Post-Traumatic Stress Disorder (PTSD). The goal is to see if this personalized therapy is safe and effective for those who have been struggling with PTSD symptoms for at least six months. If you're between 18 and 65 years old and have been diagnosed with PTSD, you might be eligible to participate. However, certain health conditions, past treatments, and other factors could affect your eligibility.

Participants in the study can expect to receive the MeRT treatment while being closely monitored by healthcare professionals. You'll need to be willing to follow the study's procedures and attend regular appointments. This trial is currently recruiting participants, so if you or someone you know is interested, it's a good opportunity to explore a potential new treatment for PTSD. Remember that the health and safety of participants are a top priority throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants must meet all inclusion criteria to qualify for enrollment in the study:
• • 1. Willing and able to consent to participate in the study
• • 2. Age 18 - 65 years
• • 3. Diagnosis of PTSD according to DSM-V criteria via CAPS-5
• • 4. Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms persisting for a minimum of 6 months prior to the Screening Visit
• • 5. Minimum PCL-5 score of 30
• • Exclusion Criteria
• Participants will be excluded from study participation if one or more of the following exclusion criteria apply:
• • 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)
• • 18. Unwilling or unable to adhere to the study treatment, data collection schedule, or study procedures, or any condition, including inability to communicate in English, which in the judgment of the Investigator might prevent the participant from completing the study, render study results uninterpretable, or represent an unacceptable safety risk to the participant or study personnel that is not otherwise listed in exclusion criteria.
• • 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