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

NCT ID: NCT02268084

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-10-31

Brief Summary

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

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Magnetic EEG/ECG-guided Resonance Therapy

Intervention Type: DEVICE

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

Interventions

Magnetic EEG/ECG-guided Resonance Therapy

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

Intervention Type: DEVICE

Sham

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

Intervention Type: DEVICE

Other Intervention Names

Magnetic Resonant Therapy; Magnetic e-Resonance Therapy; MeRT; MRT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wave Neuroscience

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Tahgva, MD

Role: PRINCIPAL_INVESTIGATOR

8583607260

Locations

Del Mar Center for Neurorestoration

San Diego, California, United States

Countries

United States

Other Identifiers

MRT-002

Identifier Type: -

Identifier Source: org_study_id