This trial is active, not recruiting.

Condition stress disorders, post-traumatic
Treatments eeg,ecg-guided transcranial magnetic stimulation, sham
Sponsor Newport Brain Research Laboratory
Start date October 2014
End date October 2016
Trial size 86 participants
Trial identifier NCT02268084, MRT-002


The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
(Sham Comparator)
Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field
eeg,ecg-guided transcranial magnetic stimulation Magnetic Resonant Therapy
A coil delivers a pulsed magnetic field to the cortex of the brain

Primary Outcomes

CAPS - Clinician Administered PTSD Scale
time frame: 2 weeks

Secondary Outcomes

PCL-M - PTSD Checklist Military version
time frame: 2 weeks
time frame: 2 weeks
WHOQOL -BREF World Health Organization Quality of Life-BREF
time frame: 2 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Willing and able to adhere to the treatment schedule and all required study visits. - Any non-Active Duty Military are included. - PCL-M > 45 - Primary diagnosis of Posttraumatic Stress Disorder rendered by the Clinician Administered PTSD Scale (CAPS) Exclusion Criteria: - Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated): History of open skull traumatic brain injury. History of clinically significant seizure disorder. - Individuals with a clinically defined neurological disorder including, but not limited to: Any condition likely to be associated with increased intracranial pressure. Space occupying brain lesion. History of cerebrovascular accident. Cerebral aneurysm. - EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing or spikes during the EEG recording. - Any type of rTMS treatment within 3 months prior to the screening visit. - Currently under antipsychotic medication treatment. - Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed. - Clinically significant abnormality or clinically significant unstable medical condition that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results. - Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning. - Any condition which in the judgment of the investigator would prevent the subject from completion of the study. - Inability to acquire a clinically satisfactory EEG/ECG on a routine basis. - Grossly abnormal electrolyte or cell blood count panels suggestive of other pathology at study initiation. - Active Duty Military are excluded.

Additional Information

Official title A Randomized Double-Blind Placebo-Controlled Trial to Evaluate Treatment Efficacy of EEG/ECD-Guided Magnetic Resonant Therapy in Combat Veterans With Post-Traumatic Stress Disorder (PTSD).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Newport Brain Research Laboratory.