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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

Tracking Information
First Submitted Date  ICMJE October 15, 2014
First Posted Date  ICMJE October 20, 2014
Last Update Posted Date October 4, 2016
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02268084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
  • PCL-M - PTSD Checklist Military version [ Time Frame: 2 weeks ]
    Pyschometric Evaluation
  • HAMD-17 HAMILTON RATING SCALE FOR DEPRESSION [ Time Frame: 2 weeks ]
    Pyschometric evaluation
  • WHOQOL -BREF World Health Organization Quality of Life-BREF [ Time Frame: 2 weeks ]
    Pyschometric evaluation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
Official Title  ICMJE 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).
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • 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
  • Device: Sham
    Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field
Study Arms  ICMJE
  • Sham Comparator: Sham
    Intervention: Device: Sham
  • Experimental: Experimental
    Intervention: Device: EEG,ECG-guided Transcranial Magnetic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 3, 2016)
86
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2014)
48
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02268084
Other Study ID Numbers  ICMJE MRT-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wave Neuroscience
Study Sponsor  ICMJE Wave Neuroscience
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wave Neuroscience
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP