Trial Outcomes & Findings for Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD (NCT NCT02268084)
NCT ID: NCT02268084
Last Updated: 2021-10-01
Results Overview
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).
COMPLETED
NA
96 participants
Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
2021-10-01
Participant Flow
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.
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
47
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Three subjects in the sham had early blind code opening due to symptomatic worsening.
|
0
|
3
|
|
Overall Study
Combination of the following, exact numbers not available: Lost to follow-up, voluntary withdrawal
|
9
|
4
|
Baseline Characteristics
Gender data unavailable for overall population.
Baseline characteristics by cohort
| Measure |
Active
n=49 Participants
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).
|
Sham
n=47 Participants
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.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=96 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=49 Participants
|
47 Participants
n=47 Participants
|
96 Participants
n=96 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=49 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=96 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=40 Participants • Gender data unavailable for overall population.
|
5 Participants
n=40 Participants • Gender data unavailable for overall population.
|
8 Participants
n=80 Participants • Gender data unavailable for overall population.
|
|
Sex: Female, Male
Male
|
37 Participants
n=40 Participants • Gender data unavailable for overall population.
|
35 Participants
n=40 Participants • Gender data unavailable for overall population.
|
72 Participants
n=80 Participants • Gender data unavailable for overall population.
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
47 participants
n=47 Participants
|
96 participants
n=96 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Active
n=40 Participants
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.
|
Sham
n=40 Participants
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.
|
|---|---|---|
|
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
|
65.25 score on a scale
Standard Deviation 8.87
|
|
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 14.70
|
-14.75 score on a scale
Standard Deviation 16.56
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Active
n=40 Participants
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.
|
Sham
n=40 Participants
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.
|
|---|---|---|
|
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
|
65.25 score on a scale
Standard Deviation 8.87
|
|
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
|
-30.9 score on a scale
Standard Deviation 13.34
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active
n=40 Participants
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.
|
Sham
n=40 Participants
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.
|
|---|---|---|
|
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
|
9.67 score on a scale
Standard Deviation 4.67
|
|
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
|
-2.03 score on a scale
Standard Deviation 4.48
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Active
n=40 Participants
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.
|
Sham
n=40 Participants
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.
|
|---|---|---|
|
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
|
9.67 score on a scale
Standard Deviation 4.67
|
|
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 5.40
|
-5.39 score on a scale
Standard Deviation 4.74
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Active
n=40 Participants
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.
|
Sham
n=40 Participants
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.
|
|---|---|---|
|
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
|
22.55 score on a scale
Standard Deviation 8.25
|
|
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
|
-8.08 score on a scale
Standard Deviation .02
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Active
n=40 Participants
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.
|
Sham
n=40 Participants
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.
|
|---|---|---|
|
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
|
22.55 score on a scale
Standard Deviation 8.25
|
|
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 2.40
|
-15.43 score on a scale
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Active
n=40 Participants
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.
|
Sham
n=40 Participants
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.
|
|---|---|---|
|
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
|
18.28 score on a scale
Standard Deviation 2.67
|
|
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
|
17.03 score on a scale
Standard Deviation 3.60
|
|
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
|
0.97 score on a scale
Standard Deviation 2.96
|
|
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
|
1.59 score on a scale
Standard Deviation 2.10
|
|
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
|
30.74 score on a scale
Standard Deviation 5.86
|
|
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
|
7.82 score on a scale
Standard Deviation 2.46
|
|
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
|
1.59 score on a scale
Standard Deviation 4.90
|
|
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
|
0.56 score on a scale
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Active
n=40 Participants
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.
|
Sham
n=40 Participants
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.
|
|---|---|---|
|
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
|
7.82 score on a scale
Standard Deviation 2.46
|
|
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
|
18.28 score on a scale
Standard Deviation 2.67
|
|
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
|
4.83 score on a scale
Standard Deviation 3.30
|
|
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
|
17.02 score on a scale
Standard Deviation 3.60
|
|
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
|
3.20 score on a scale
Standard Deviation 3.23
|
|
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
|
2.86 score on a scale
Standard Deviation 2.06
|
|
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
|
30.74 score on a scale
Standard Deviation 5.86
|
|
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
|
2.83 score on a scale
Standard Deviation 3.69
|
Adverse Events
Sham
Active
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham
n=47 participants at risk
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
|
Active
n=49 participants at risk
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
|
|---|---|---|
|
General disorders
Headache (Mild)
|
2.1%
1/47 • 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.
|
8.2%
4/49 • 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.
|
Additional Information
Meagan Kovacs, Clinical and Regulatory Affairs Manager
Wave Neuroscience
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place