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

This study is currently recruiting participants.
Verified April 2017 by Jianzhong Zhang, 72nd Medical Group, Tinker Air Force Base
Sponsor:
ClinicalTrials.gov Identifier:
NCT02824445
First Posted: July 6, 2016
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
brain treatment center; MacDill AFB
Information provided by (Responsible Party):
Jianzhong Zhang, 72nd Medical Group, Tinker Air Force Base
  Purpose
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.

Condition Intervention
Post-Traumatic Stress Disorders Device: individualized Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Air Force Base

Resource links provided by NLM:


Further study details as provided by Jianzhong Zhang, 72nd Medical Group, Tinker Air Force Base:

Primary Outcome Measures:
  • 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. [ Time Frame: At the end of week of 4 and 8. ]
    The change of PCL-M and CPFQ scores from baseline and at weeks of 4 and 8 are assessed.


Estimated Enrollment: 50
Actual Study Start Date: May 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham
The double-blind is used during the first 2 weeks. From week 3 and on, the study becomes open label. Subjects in Group I (active MeRT treatment group) will continue receive active MeRT treatment for W3/4; subjects in Group II (placebo/sham group) will receive active MeRT treatment from W3 to W6 for 4 weeks. All subjects will receive 4 weeks active MeRT treatment. The study ends in 8th wk. The data collection points are baseline, weeks of 2, 4, 6, and 8. The data from weeks 1-2 (Phase I) will be utilized to analyze the safety and any effect of MRT procedure may have over placebo. The data from weeks 3 on (Phase II) will be used to address if any benefit of longer MeRT treatment (4 vs 2 weeks). The study design offers both groups 4 weeks of the experimental therapy in a row. This will provide potentially equal benefit to those participants assuming that MeRT helps to improve PTSD symptoms.
Device: individualized Transcranial Magnetic Stimulation
Other Name: EEG-GUIDED MAGNETIC RESONANT THERAPY (MeRT)
Experimental: Treatment
The double-blind is used during the first 2 weeks. From week 3 and on, the study becomes open label. Subjects in Group I (active MeRT treatment group) will continue receive active MeRT treatment for W3/4; subjects in Group II (placebo/sham group) will receive active MeRT treatment from W3 to W6 for 4 weeks. All subjects will receive 4 weeks active MeRT treatment. The study ends in 8th wk. The data collection points are baseline, weeks of 2, 4, 6, and 8. The data from weeks 1-2 (Phase I) will be utilized to analyze the safety and any effect of MRT procedure may have over placebo. The data from weeks 3 on (Phase II) will be used to address if any benefit of longer MeRT treatment (4 vs 2 weeks). The study design offers both groups 4 weeks of the experimental therapy in a row. This will provide potentially equal benefit to those participants assuming that MeRT helps to improve PTSD symptoms.
Device: individualized Transcranial Magnetic Stimulation
Other Name: EEG-GUIDED MAGNETIC RESONANT THERAPY (MeRT)

  Eligibility

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824445


Locations
United States, Oklahoma
72d Medical Group Recruiting
Oklahoma City, Oklahoma, United States, 73145
Contact: Jianzhong Zhang, MD    405-582-6610    jianzhong.zhang@us.af.mil   
Contact: Shane Biedermann, MD    405-582-6610      
Sub-Investigator: Gail Bates, MD         
Sub-Investigator: James Gentry, MD         
Sponsors and Collaborators
72nd Medical Group, Tinker Air Force Base
brain treatment center; MacDill AFB
  More Information

Responsible Party: Jianzhong Zhang, Chief, Aeromedical Services, 72nd Medical Group, Tinker Air Force Base
ClinicalTrials.gov Identifier: NCT02824445     History of Changes
Other Study ID Numbers: FWH20150038H
First Submitted: June 23, 2016
First Posted: July 6, 2016
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders