Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD

A Randomized Double-Blind Placebo-Controlled Trial to Evaluate Treatment Efficacy of EEG/ECD-Guided Magnetic Resonant Therapy in Combat Veterans With Post-Traumatic Stress Disorder (PTSD).

The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Device: Sham; Device: Magnetic EEG/ECG-guided Resonance Therapy

Detailed Description

This clinical trial is a prospective, randomized, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of EEG/ECG-guided magnetic resonant therapy (MRT) in combat veterans with Posttraumatic Stress Disorder. A total of 2004 subjects will be treated in two phases: double-blind and open label.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92014
      • Del Mar Center for Neurorestoration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Willing and able to adhere to the treatment schedule and all required study visits.
• Any non-Active Duty Military are included.
• PCL-M > 45
• Primary diagnosis of Posttraumatic Stress Disorder rendered by the Clinician Administered PTSD Scale (CAPS)

Exclusion Criteria:

• 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.
• EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing or spikes during the 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.
• Inability to acquire a clinically satisfactory EEG/ECG on a routine basis.
• Grossly abnormal electrolyte or cell blood count panels suggestive of other pathology at study initiation.
• Active Duty Military are excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Stimulation; Sham treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 2 weeks (double blind phase only) using a sham device. Sham device mimics the same noise and sensation of active treatment.	Device: Sham; Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field
Active Comparator: Active sTMS; Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 2 weeks (double blind phase) and 2 additional weeks for all subjects (open label) with Synchronized Transcranial Magnetic Stimulation (sTMS), using an active device.	Device: Magnetic EEG/ECG-guided Resonance Therapy; A coil delivers a pulsed magnetic field to the cortex of the brain; Other Names: MRT; Magnetic Resonant Therapy; Magnetic e-Resonance Therapy; MeRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase	Mean change in the PCL-M total scores of subjects from baseline to end of the double-blind treatment phase, compared between active and sham groups. The Post-traumatic Stress Disorder Checklist - Military Version (PCL-M) is a 17-item metric for PTSD symptoms, as defined by the DSM-IV. Each symptom is scored on a scale from 1-5; total scores range from 17 (least symptomatic) to 85 (most symptomatic).	Baseline (Day 0) and End of Double-Blind Treatment (Week 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase	Mean change in the PCL-M total scores of subjects from baseline to end of the open-label treatment phase, compared between active and sham groups. The Post-traumatic Stress Disorder Checklist - Military Version (PCL-M) is a 17-item metric for PTSD symptoms, as defined by the DSM-IV. Each symptom is scored on a scale from 1-5; total scores range from 17 (least symptomatic) to 85 (most symptomatic).	Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment	Mean change in the PSQI-A total scores from baseline to end of the double-blind treatment, compared between active and sham groups. The Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) is a 7-item metric to rate sleep disturbance items that are commonly reported with PTSD. Total scores range from 0 (least severe) to 21 (most severe), where scores greater than or equal to 4 have been used to identify adults with PTSD.	Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment	Mean change is the PSQI-A total scores from baseline to end of the open-label treatment, compared between active and sham groups. The Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) is a 7-item metric to rate sleep disturbance items that are commonly reported with PTSD. Total scores ranges from 0 (least severe) to 21 (most severe), where scores greater than or equal to 4 have been used to identify adults with PTSD.	Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment	Mean change in the HAMD-17 total scores from baseline to end of double-blind treatment, compared between active and sham The Hamilton Depression Rating Scale (HAMD-17) is a 17-item metric to rate subjects on severity of depressive symptoms. Total scores range from 0-52, with higher scores indicating more severe symptoms; a score of 0-7 is generally accepted to be within normal range (or in remission), while a score of 20 or greater indicates moderate to severe depression.	Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment	Mean change in the HAMD-17 total scores from baseline to end of open-label treatment, compared between active and sham groups. The Hamilton Depression Rating Scale (HAMD-17) is a 17-item metric to rate subjects on severity of depressive symptoms. Total scores range from 0-52, with higher scores indicating more severe symptoms; a score of 0-7 is generally accepted to be within normal range (or in remission), while a score of 20 or greater indicates moderate to severe depression.	Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment	Mean change in each WHO-QOL domain score from baseline to end of treatment, compared between active and sham groups. The World Health Organization's Quality of Life Index - BREF Version (WHO-QOL) is a metric used to establish the subject's quality of life in four domains: physical health (D1), psychological health (D2), social relationships (D3), and environmental health (D4). Higher scores indicate a more positive quality of life; D1 has a score range of 7-35, D2 has a range of 6-30, D3 has a range of 3-15, D4 has a range of 8-40.	Baseline and End of Double-Blind (Week 2)
Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment	Mean change in each WHO-QOL domain score from baseline to end of open-label treatment, compared between active and sham groups. The World Health Organization's Quality of Life Index - BREF Version (WHO-QOL) is a metric used to establish the subject's quality of life in four domains: physical health (D1), psychological health (D2), social relationships (D3), and environmental health (D4). Higher scores indicate a more positive quality of life; D1 has a score range of 7-35, D2 has a range of 6-30, D3 has a range of 3-15, D4 has a range of 8-40.	Baseline (Day 0) and End of Open-Label (Week 4)

Collaborators and Investigators

• Sponsor: Wave Neuroscience
• Investigators: Principal Investigator: Alex Tahgva, MD, 8583607260

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; EEG; TMS
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MRT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No