Stress Disorders, Post-Traumatic
Conditions
Keywords
PTSD, TMS, EEG
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.
Interventions
DEVICEMagnetic EEG/ECG-guided Resonance Therapy
A coil delivers a pulsed magnetic field to the cortex of the brain
DEVICESham
Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field
Sponsors
Wave Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Sham controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase | Baseline (Day 0) and End of Double-Blind Treatment (Week 2) | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment | Baseline (Day 0) and End of Double-Blind Treatment (Week 2) | 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 | Baseline (Day 0) and End of Open-Label Treatment (Week 4) | 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 | Baseline (Day 0) and End of Double-Blind Treatment (Week 2) | 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 Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase | Baseline (Day 0) and End of Open-Label Treatment (Week 4) | 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 World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Baseline and End of Double-Blind (Week 2) | 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 | Baseline (Day 0) and End of Open-Label (Week 4) | 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. |
| Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment | Baseline (Day 0) and End of Open-Label Treatment (Week 4) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 49 |
| 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. | 47 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Combination of the following, exact numbers not available: Lost to follow-up, voluntary withdrawal | 9 | 4 |
| Overall Study | Three subjects in the sham had early blind code opening due to symptomatic worsening. | 0 | 3 |
Baseline characteristics
| Characteristic | Active | Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 47 Participants | 96 Participants |
| Region of Enrollment United States | 49 participants | 47 participants | 96 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 37 Participants | 35 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 49 |
| other Total, other adverse events | 1 / 47 | 4 / 49 |
| serious Total, serious adverse events | 0 / 47 | 0 / 49 |
Outcome results
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).
Time frame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase | Change Between Baseline and Week 2 | -22.45 score on a scale | Standard Deviation 14.7 |
| Active | Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase | Baseline | 65.78 score on a scale | Standard Deviation 9.71 |
| Sham | Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase | Change Between Baseline and Week 2 | -14.75 score on a scale | Standard Deviation 16.56 |
| Sham | Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase | Baseline | 65.25 score on a scale | Standard Deviation 8.87 |
Comparison: Null hypothesis is that the active treatment group does not differ from the sham group in changes in the PCL-M total scores.p-value: 0.007ANOVA
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.
Time frame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment | Baseline | 24.23 score on a scale | Standard Deviation 8.01 |
| Active | Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment | Change Between Baseline and Week 2 | -11.33 score on a scale | Standard Deviation 1.77 |
| Sham | Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment | Baseline | 22.55 score on a scale | Standard Deviation 8.25 |
| Sham | Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment | Change Between Baseline and Week 2 | -8.08 score on a scale | Standard Deviation 0.02 |
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.
Time frame: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment | Baseline | 24.23 score on a scale | Standard Deviation 8.01 |
| Active | Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) | -16.60 score on a scale | Standard Deviation 2.4 |
| Sham | Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment | Baseline | 22.55 score on a scale | Standard Deviation 8.25 |
| Sham | Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) | -15.43 score on a scale | Standard Deviation 2 |
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.
Time frame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment | Baseline | 10.85 score on a scale | Standard Deviation 4.95 |
| Active | Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment | Change Between Baseline and Week 2 | -4.66 score on a scale | Standard Deviation 5.54 |
| Sham | Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment | Baseline | 9.67 score on a scale | Standard Deviation 4.67 |
| Sham | Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment | Change Between Baseline and Week 2 | -2.03 score on a scale | Standard Deviation 4.48 |
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.
Time frame: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment | Baseline | 10.84 score on a scale | Standard Deviation 4.95 |
| Active | Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) | -7.23 score on a scale | Standard Deviation 5.4 |
| Sham | Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment | Baseline | 9.67 score on a scale | Standard Deviation 4.67 |
| Sham | Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) | -5.39 score on a scale | Standard Deviation 4.74 |
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).
Time frame: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase | Baseline | 65.78 score on a scale | Standard Deviation 9.71 |
| Active | Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase | Change from Baseline to Week 4 (End of Open-Label) | -32.53 score on a scale | Standard Deviation 13.07 |
| Sham | Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase | Baseline | 65.25 score on a scale | Standard Deviation 8.87 |
| Sham | Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase | Change from Baseline to Week 4 (End of Open-Label) | -30.9 score on a scale | Standard Deviation 13.34 |
p-value: 0.326t-test, 2 sided
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.
Time frame: Baseline (Day 0) and End of Open-Label (Week 4)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Baseline (D1) | 18.89 score on a scale | Standard Deviation 2.82 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) (D1) | 5.56 score on a scale | Standard Deviation 3.54 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Baseline (D2) | 16.18 score on a scale | Standard Deviation 2.71 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) (D2) | 4.50 score on a scale | Standard Deviation 4.21 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Baseline (D3) | 7.37 score on a scale | Standard Deviation 2.78 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) (D3) | 3.19 score on a scale | Standard Deviation 2.67 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Baseline (D4) | 27.00 score on a scale | Standard Deviation 5.01 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) (D4) | 5.47 score on a scale | Standard Deviation 3.71 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) (D4) | 2.83 score on a scale | Standard Deviation 3.69 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Baseline (D1) | 18.28 score on a scale | Standard Deviation 2.67 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Baseline (D3) | 7.82 score on a scale | Standard Deviation 2.46 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) (D1) | 4.83 score on a scale | Standard Deviation 3.3 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Baseline (D4) | 30.74 score on a scale | Standard Deviation 5.86 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Baseline (D2) | 17.02 score on a scale | Standard Deviation 3.6 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) (D3) | 2.86 score on a scale | Standard Deviation 2.06 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment | Change from Baseline to Week 4 (End of Open-Label) (D2) | 3.20 score on a scale | Standard Deviation 3.23 |
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.
Time frame: Baseline and End of Double-Blind (Week 2)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Baseline (D1) | 18.89 score on a scale | Standard Deviation 2.87 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Change Between Baseline and Week 2 (D1) | 3.11 score on a scale | Standard Deviation 3.82 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Baseline (D2) | 16.18 score on a scale | Standard Deviation 2.71 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Baseline (D3) | 7.36 score on a scale | Standard Deviation 2.78 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Change Between Baseline and Week 2 (D3) | 1.89 score on a scale | Standard Deviation 2.73 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Change Between Baseline and Week 2 (D4) | 2.76 score on a scale | Standard Deviation 3.89 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Change Between Baseline and Week 2 (D2) | 2.63 score on a scale | Standard Deviation 3.74 |
| Active | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Baseline (D4) | 27.00 score on a scale | Standard Deviation 5.01 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Baseline (D3) | 7.82 score on a scale | Standard Deviation 2.46 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Baseline (D1) | 18.28 score on a scale | Standard Deviation 2.67 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Change Between Baseline and Week 2 (D4) | 0.56 score on a scale | Standard Deviation 3.31 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Change Between Baseline and Week 2 (D1) | 1.59 score on a scale | Standard Deviation 4.9 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Change Between Baseline and Week 2 (D3) | 1.59 score on a scale | Standard Deviation 2.1 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Baseline (D2) | 17.03 score on a scale | Standard Deviation 3.6 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Change Between Baseline and Week 2 (D2) | 0.97 score on a scale | Standard Deviation 2.96 |
| Sham | Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment | Baseline (D4) | 30.74 score on a scale | Standard Deviation 5.86 |