Back to resultsTrial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic EEG/ECG-guided Resonance Therapy
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, TMS, EEG
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.
Sites / Locations
- Del Mar Center for Neurorestoration
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham Stimulation
Active sTMS
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02268084
Brief Title
Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
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 Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wave Neuroscience
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
PTSD, TMS, EEG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sham controlled
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Active sTMS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic EEG/ECG-guided Resonance Therapy
Other Intervention Name(s)
Magnetic Resonant Therapy, Magnetic e-Resonance Therapy, MeRT, MRT
Intervention Description
A coil delivers a pulsed magnetic field to the cortex of the brain
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field
Primary Outcome Measure Information:
Title
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase
Description
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).
Time Frame
Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Secondary Outcome Measure Information:
Title
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase
Description
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).
Time Frame
Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Title
Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment
Description
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.
Time Frame
Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Title
Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment
Description
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.
Time Frame
Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Title
Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment
Description
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.
Time Frame
Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Title
Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment
Description
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.
Time Frame
Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Title
Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment
Description
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.
Time Frame
Baseline and End of Double-Blind (Week 2)
Title
Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment
Description
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.
Time Frame
Baseline (Day 0) and End of Open-Label (Week 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Tahgva, MD
Organizational Affiliation
8583607260
Official's Role
Principal Investigator
Facility Information:
Facility Name
Del Mar Center for Neurorestoration
City
San Diego
State/Province
California
ZIP/Postal Code
92014
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
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