To Evaluate the Efficacy of EEG-guided Magnetic Resonant Therapy in War Veterans With Posttraumatic Stress Disorder
| Status: | Terminated |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/21/2019 |
| Start Date: | May 2015 |
| End Date: | May 28, 2018 |
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
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.
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.
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
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