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

NCT02268084 | Completed Results

• 1 other identifier: MRT-002
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD; TMS; EEG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase

  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

  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

  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

  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

  Baseline (Day 0) and End of Open-Label Treatment (Week 4)

Study Arms (2)

Sham Stimulation

SHAM COMPARATOR

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

Active sTMS

ACTIVE COMPARATOR

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

Interventions

Magnetic EEG/ECG-guided Resonance Therapy DEVICE

A coil delivers a pulsed magnetic field to the cortex of the brain

Also known as: Magnetic Resonant Therapy, Magnetic e-Resonance Therapy, MeRT, MRT

Active sTMS

Sham DEVICE

Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field

Sham Stimulation

Eligibility Criteria

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

You may qualify if:

• 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)

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.
• 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.

Sponsors & Collaborators

• Wave Neuroscience: lead

Study Sites (1)

Del Mar Center for Neurorestoration

San Diego, California, 92014, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

* Sham condition imperfect; the sham device inadvertently delivers some treatment through magnetically shielded coil and forehead stimulation * Placebo effects may modulate brain regions and neural networks similar to active treatment; it is common for both sham and active groups to show clinical improvement * Gender influences PTSD symptoms and severity and response to treatment/efficacy

Results Point of Contact

• Title: Meagan Kovacs, Clinical and Regulatory Affairs Manager
• Organization: Wave Neuroscience

meagan@waveneuro.com

9492292869

Study Officials

• Alex Tahgva, MD

  8583607260

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sham controlled

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 1, 2021
• Results First Posted: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)