Phase
Condition
Traumatic Brain Injury
Neurologic Disorders
Memory Loss
Treatment
Active MeRT Treatment
Sham MeRT Treatment
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must meet all inclusion criteria to qualify for enrollment in the study:
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
Participants will be excluded from study participation if one or more of the following exclusion criteria apply:
Index trauma occurred before the age of 16 years
History of open skull injury
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
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
History of any type of ECT, rTMS, or MeRT treatment
Treated within 30 days of the Screening Visit with any antipsychotic medication
Treated within 30 days of the Screening Visit with any benzodiazepine or anticonvulsant medications
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
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
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)
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
Pregnant, or female unwilling to use effective birth control during the course of the trial
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)
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.
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
An elevated risk of suicide or violence to others
Current psychotherapeutic treatment, expected to continue throughout the trial, that was begun in the preceding 60 days at the time of the Screening Visit
Study Design
Study Description
Connect with a study center
BrainHealth Solutions
Costa Mesa, California 92626
United StatesSite Not Available
SoCal Neuroscience Research Unit
San Diego, California 92103
United StatesTerminated
MacDill Air Force Base
Macdill Air Force Base, Florida 33621
United StatesSite Not Available
Columbus Brain Research Center
Columbus, Ohio 43219
United StatesActive - Recruiting
Center for Interventional Pain and Spine
Bryn Mawr, Pennsylvania 19010
United StatesActive - Recruiting
Texas A&M Research Center
Dallas, Texas 75246
United StatesSite Not Available
Texas A&M Research Center
Plano, Texas 75093
United StatesActive - Recruiting
Seattle Neuropsychiatric Treatment Center (Seattle NTC)
Bellevue, Washington 98004
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.