To Evaluate the Efficacy of EEG-guided Magnetic Resonant Therapy in War Veterans With Posttraumatic Stress Disorder

Post-Traumatic Stress Disorders Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02824445
• Other study ID #: FWH20150038H
• Status: Terminated
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 28, 2018
• Est. primary completion date: May 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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.