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The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic EEG/ECG-guided Resonance Therapy | Device | A coil delivers a pulsed magnetic field to the cortex of the brain |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Tahgva, MD | 8583607260 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Del Mar Center for Neurorestoration | San Diego | California | 92014 | United States |
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Subjects were screened for eligibility; subjects with history of seizure disorder, history of intracranial lesion, history of intracranial implant, prior transcranial magnetic therapy, and inability to adhere to the treatment schedule were excluded from the study. Eligible subjects were provided with study consent forms. No medication wash-out was required.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Magnetic EEG/ECG-Guided Resonance Therapy treatments use a coil to deliver pulsed magnetic fields to the cortex of the brain. Active treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for four weeks (two weeks of double-blind treatment, two weeks of open-label treatment). |
| FG001 | Sham | Sham treatment devices simulate the behavior of the active devices by mimicking the same noise and sensation of active treatment without applying the magnetic field. Sham treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for two weeks. Active treatment devices were used for the additional 2 weeks of open-label treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Magnetic EEG/ECG-Guided Resonance Therapy treatments use a coil to deliver pulsed magnetic fields to the cortex of the brain. Active treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for four weeks (two weeks of double-blind treatment, two weeks of open-label treatment). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 96 participants were randomized into the trial, 86 completed treatment protocol. Of those, 6 were excluded from final analyses for failing to meet protocol requirements. Analyses were performed on the remaining 80 subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) and End of Double-Blind Treatment (Week 2) |
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Adverse events were monitored from date of consent through 30 days of last treatment date, on each treatment or follow-up day.
Adverse events were collected on every treatment and assessment visit through self-reporting and observation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham | 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). Sham treatment mimicks same noise and sensation of active treatment. Sham: Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache (Mild) | General disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meagan Kovacs, Clinical and Regulatory Affairs Manager | Wave Neuroscience | 9492292869 | meagan@waveneuro.com |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Sham controlled
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| Sham | Device | Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field |
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| 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | Baseline (Day 0) and End of Open-Label Treatment (Week 4) |
| 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. | Baseline and End of Double-Blind (Week 2) |
| 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. | Baseline (Day 0) and End of Open-Label (Week 4) |
| Sham |
Shame treatment devices simulate the behavior of the active devices by mimicking the same noise and sensation of active treatment without applying the magnetic field. Sham treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for two weeks. Active devices were used for the additional two weeks of open-label treatment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Gender data unavailable for overall population. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Magnetic EEG-Guided Resonance Therapy Treatments use a coil to deliver pulsed magnetic fields to the cortex of the brain. Active treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for four weeks (two weeks of double blind treatment, two weeks of open-label treatment.
| OG001 | Sham | Sham treatment devices simulate the behavior of the active devices by mimicking the same noise and sensation of active treatment without applying the magnetic field. Sham treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for two weeks. Active devices were used for the additional two weeks of open-label treatment. |
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| Secondary | 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). | 96 participants were randomized into the trial, 86 completed treatment protocol. Of those, 6 were excluded from final analyses for failing to meet the protocol requirements. Analyses were performed on the remaining 80 subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) and End of Open-Label Treatment (Week 4) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) and End of Double-Blind Treatment (Week 2) |
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| Secondary | 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. | 96 participants were randomized into the trial, 86 completed treatment protocol. Of those, 6 were excluded from the final analyses for failing to meet the protocol requirements. Analyses were performed on the remaining 80 subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) and End of Open-Label Treatment (Week 4) |
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| Secondary | 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. | 96 participants were randomized into the trial, 86 completed treatment protocol. Of those, 6 were excluded from the final analyses for failling to meet the protocol requirements. Analyses were performed on the remaining 80 subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) and End of Double-Blind Treatment (Week 2) |
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| Secondary | 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. | 96 participants were randomized into the trial, 86 completed treatment protocol. Of those, 6 were excluded from the final analyses for failing to meet protocol requirements. Analyses were performed on the remaining 80 subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) and End of Open-Label Treatment (Week 4) |
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| Secondary | 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. | 96 participants were randomized into the trial, 86 completed treatment protocol. Of those, 6 were excluded from final analyses for failing to meet protocol requirements. Analyses were performed on the remaining 80 subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Double-Blind (Week 2) |
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| Secondary | 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. | 96 participants were randomized into the trial, 86 completed treatment protocol. Of those, 6 were excluded from final analyses for failing to meet protocol requirements. Analyses were performed on the remaining 80 subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) and End of Open-Label (Week 4) |
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| EG001 | Active | 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). Magnetic EEG/ECG-guided Resonance Therapy: A coil delivers a pulsed magnetic field to the cortex of the brain | 0 | 49 | 0 | 49 | 4 | 49 |
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