Stress Disorders, Post-Traumatic Clinical Trial
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).
NCT number | NCT02268084 |
Other study ID # | MRT-002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | October 2016 |
Verified date | September 2021 |
Source | Wave Neuroscience |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.
Status | Completed |
Enrollment | 96 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Del Mar Center for Neurorestoration | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Wave Neuroscience |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). |
Baseline (Day 0) and End of Double-Blind Treatment (Week 2) | |
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). |
Baseline (Day 0) and End of Open-Label Treatment (Week 4) | |
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. |
Baseline (Day 0) and End of Double-Blind Treatment (Week 2) | |
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. |
Baseline (Day 0) and End of Open-Label Treatment (Week 4) | |
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. |
Baseline (Day 0) and End of Double-Blind Treatment (Week 2) | |
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. |
Baseline (Day 0) and End of Open-Label Treatment (Week 4) | |
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. |
Baseline and End of Double-Blind (Week 2) | |
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. |
Baseline (Day 0) and End of Open-Label (Week 4) |
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