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

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ClinicalTrials.gov Identifier: NCT02268084
Recruitment Status : Unknown
Verified October 2016 by Wave Neuroscience.
Recruitment status was:  Active, not recruiting
First Posted : October 20, 2014
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Wave Neuroscience

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

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Device: EEG,ECG-guided Transcranial Magnetic Stimulation Device: Sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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).
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham Device: Sham
Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field

Experimental: Experimental Device: EEG,ECG-guided Transcranial Magnetic Stimulation
A coil delivers a pulsed magnetic field to the cortex of the brain
Other Name: Magnetic Resonant Therapy




Primary Outcome Measures :
  1. CAPS - Clinician Administered PTSD Scale [ Time Frame: 2 weeks ]
    The primary efficacy outcome measure will consist of the Percentage (%) change in CAPS total severity score at the end of week 2 of treatment. Treatment efficacy will be defined as a statistically significantly greater reduction in mean CAPS total score of the active treatment group compared to the placebo/sham treatment group.


Secondary Outcome Measures :
  1. PCL-M - PTSD Checklist Military version [ Time Frame: 2 weeks ]
    Pyschometric Evaluation

  2. HAMD-17 HAMILTON RATING SCALE FOR DEPRESSION [ Time Frame: 2 weeks ]
    Pyschometric evaluation

  3. WHOQOL -BREF World Health Organization Quality of Life-BREF [ Time Frame: 2 weeks ]
    Pyschometric evaluation



Information from the National Library of Medicine

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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:

  • 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.

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): NCT02268084


Locations
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United States, California
Del Mar Center for Neurorestoration
San Diego, California, United States, 92014
Sponsors and Collaborators
Wave Neuroscience

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Responsible Party: Wave Neuroscience
ClinicalTrials.gov Identifier: NCT02268084     History of Changes
Other Study ID Numbers: MRT-002
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Keywords provided by Wave Neuroscience:
PTSD
TMS
EEG
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders