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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02824445
Other study ID # FWH20150038H
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date May 28, 2018

Study information

Verified date December 2019
Source 72nd Medical Group, Tinker Air Force Base
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After 13 years of war, PTSD has become pervasive in service members. Traditionally it is evaluated by PTSD Checklist Military Version (PCL-M) and treated with cognitive processing therapy, prolonged exposure therapy and medication management with limited success. Repetitive Transcranial Magnetic Stimulation (TMS) has shown efficacy for improving individual cognitive function in the past decades, both in healthy population and in patients with depression. TMS has been approved by the FDA in treatment of major depressive disorder and migraine headaches. Magnetic EEG guided Resonant Treatment (MeRT) is a form of individualized TMS based on member's EEG/ECG input. Investigators propose to use MeRT to treat veterans with war-related PTSD, a syndrome that includes depressive and anxious symptoms; it is likely that MeRT (namely TMS) will be beneficial and comparable to or better than the current FDA approved methods for treating PTSD.


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Study Design


Intervention

Device:
individualized Transcranial Magnetic Stimulation


Locations

Country Name City State
United States 72d Medical Group Oklahoma City Oklahoma

Sponsors (2)

Lead Sponsor Collaborator
72nd Medical Group, Tinker Air Force Base brain treatment center; MacDill AFB

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The outcome will be measured by PTSD checklist -- military version (PCL-M) scoring criteria for PTSD. The outcome is measured additionally by Cognitive and Physical Functioning Questionnaire (CPFQ) for cognitive function improvement among the subjects. The change of PCL-M and CPFQ scores from baseline and at weeks of 4 and 8 are assessed. At the end of week of 4 and 8.
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