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

NCT02824445 | Terminated DMC

• 1 other identifier: FWH20150038H
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Sham

SHAM COMPARATOR

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

Treatment

EXPERIMENTAL

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

Interventions

individualized Transcranial Magnetic Stimulation DEVICE

Also known as: EEG-GUIDED MAGNETIC RESONANT THERAPY (MeRT)

Sham; Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• PCL-M score \> 45
• Age between 18 and 55 years (at day of informed consent)
• Willing and able to adhere to the treatment schedule and all required study visits.
• Must be clinically stable for at least 30 days on or off any PTSD medication before the trial treatment

You may not qualify if:

• 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
• 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
• Abnormalities that indicate risk of seizure, i.e., focal or general slowing or spikes during EEG recording
• Any type of rTMS treatment within 3 months prior to the screening visit
• Currently under antipsychotic medication treatment
• 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
• 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
• Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning
• Any condition which in the judgment of the investigator would prevent the subject from completion of the study

Sponsors & Collaborators

• 72nd Medical Group, Tinker Air Force Base: lead
• brain treatment center; MacDill AFB: collaborator

Study Sites (1)

72d Medical Group

Oklahoma City, Oklahoma, 73145, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Aeromedical Services

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 6, 2016
• Study Start: May 1, 2015
• Primary Completion: May 28, 2018
• Study Completion: May 28, 2018
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)