Clinical trial NCT02824445: To Evaluate the Efficacy of EEG-guided Magnetic Resonant Therapy in War Veterans With Posttraumatic Stress Disorder
Official title: A Pilot Study to Evaluate the Efficacy of EEG/ECG-guided Magnetic Resonant Therapy (MeRT) in War Veterans With Posttraumatic Stress Disorder (PTSD) at Tinker and MacDill Air Force Bases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-Traumatic Stress Disorders
Lead sponsor: 72nd Medical Group, Tinker Air Force Base
Sponsor class: FED
Collaborators: name: brain treatment center; MacDill AFB
First posted: 2016-07-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Have diagnosis of combat-related PTSD by DSM-V criteria, diagnosed via clinical interview by psychologist or psychiatrist (note: combat pilots of remotely piloted aircraft are included)
2. PCL-M score \> 45
3. Age between 18 and 55 years (at day of informed consent)
4. Willing and able to adhere to the treatment schedule and all required study visits.
5. Must be clinically stable for at least 30 days on or off any PTSD medication before the trial treatment

Exclusion Criteria:

1. 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
2. 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
3. Abnormalities that indicate risk of seizure, i.e., focal or general slowing or spikes during EEG recording
4. Any type of rTMS treatment within 3 months prior to the screening visit
5. Currently under antipsychotic medication treatment
6. 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
7. 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
8. Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning
9. Any condition which in the judgment of the investigator would prevent the subject from completion of the study
10. Inability to acquire a clinically satisfactory EEG/ECG on a routine basis
11. Grossly abnormal electrolyte or cell blood count panels suggestive of other pathology at study initiation
12. Pregnant or breastfeeding women

Primary outcomes:
measure: 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.
timeFrame: At the end of week of 4 and 8.
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: 72d Medical Group
state: Oklahoma
Study officials:
References: