Status:
COMPLETED
Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
Lead Sponsor:
Wave Neuroscience
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.
Detailed Description
This clinical trial is a prospective, randomized, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of EEG/ECG-guided magnetic resonant therapy (MRT) in combat vete...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT02268084
Start Date
October 1 2014
End Date
October 1 2016
Last Update
October 1 2021
Active Locations (1)
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1
Del Mar Center for Neurorestoration
San Diego, California, United States, 92014