COMPLETED

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

Conditions

PostTraumatic Stress Disorder Traumatic Brain Injury Postconcussive Symptoms PTSD Concussion TBI TMS Post Traumatic Stress Disorder Post-traumatic Stress Disorder MERT rTMS Transcranial Magnetic Stimulation Repetitive Transcranial Magnetic Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Prospective, Double Blind, Randomized, Sham-Controlled, Clinical Trial to Evaluate The Safety And Efficacy Of Biometrics-Guided Magnetic EEG Resonance Therapy (MeRT) Treatment Of Post-Traumatic Stress Disorder

Quick Facts

Study Start:2022-04-04

Study Completion:2025-11-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT02990793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

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
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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Kenneth Ramos, MD,PhD

PRINCIPAL_INVESTIGATOR

Texas A&M University

Adele Gilpin, PhD,JD

STUDY_CHAIR

GilpinPhillips BIOMED, LLC

Study Locations (Sites)

BrainHealth Solutions

Costa Mesa, California, 92626

United States

VA Long Beach Healthcare System

Long Beach, California, 90822

United States

SoCal Neuroscience Research Unit

San Diego, California, 92103

United States

UNC Rex Hospital

Raleigh, North Carolina, 27607

United States

Columbus Brain Research Center

Columbus, Ohio, 43219

United States

Center for Interventional Pain and Spine

Bryn Mawr, Pennsylvania, 19010

United States

Texas A&M Research Center

Plano, Texas, 75093

United States

Seattle Neuropsychiatric Treatment Center (Seattle NTC)

Bellevue, Washington, 98004

United States

Collaborators and Investigators

Sponsor: Wave Neuroscience

Kenneth Ramos, MD,PhD, PRINCIPAL_INVESTIGATOR, Texas A&M University
Adele Gilpin, PhD,JD, STUDY_CHAIR, GilpinPhillips BIOMED, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-04

Study Completion Date2025-11-04

Study Record Updates

Study Start Date2022-04-04

Study Completion Date2025-11-04

Terms related to this study

Keywords Provided by Researchers

PTSD
Concussion
TBI
TMS
Post Traumatic Stress Disorder
Posttraumatic Stress Disorder
Post-traumatic Stress Disorder
MERT
rTMS
Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation
Traumatic Brain Injury

Additional Relevant MeSH Terms

PostTraumatic Stress Disorder
Traumatic Brain Injury
Postconcussive Symptoms