Trial Outcomes & Findings for Neuromodulation for Post-Traumatic Stress Disorder (NCT NCT02377089)
NCT ID: NCT02377089
Last Updated: 2022-06-08
Results Overview
Treatment efficacy as measured by change in Clinician-Administered Post Traumatic Stress Disorder score for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition at baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 80. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
8 weeks (Baseline visit and Week 8 visit)
Results posted on
2022-06-08
Participant Flow
Recruitment at the VA Greater Los Angeles and VA Long Beach.
95 Potential participants were assessed for eligibility, of the 95, 23 participants did not meet the study criteria, and 72 participants were consented for the study. Of the 72 consented participants, 12 subjects dropped prior to randomization resulting in 60 randomized, evaluable participants.
Participant milestones
| Measure |
Sham
The stimulators are the same device for the active and sham treatment conditions.
Placebo: Subjects will be randomized to treatment with either active or sham Trigeminal Nerve Stimulation (TNS) for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
Active
The stimulators are the same device for the active and sham treatment conditions.
Trigeminal Nerve Stimulation (TNS): Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sham
n=31 Participants
The stimulators are the same device for the active and sham treatment conditions.
Placebo: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
Active
n=29 Participants
The stimulators are the same device for the active and sham treatment conditions.
Trigeminal Nerve Stimulation: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=31 Participants
|
29 Participants
n=29 Participants
|
60 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
41.33 years
n=31 Participants
|
35.57 years
n=29 Participants
|
37.71 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=31 Participants
|
2 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=31 Participants
|
27 Participants
n=29 Participants
|
58 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
31 Participants
n=31 Participants
|
29 Participants
n=29 Participants
|
60 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 8 weeks (Baseline visit and Week 8 visit)Population: Discrepancy in subjects randomized and subjects analyzed reflect the number of subjects who were randomized but discontinued intervention prior to reaching an evaluable time point.
Treatment efficacy as measured by change in Clinician-Administered Post Traumatic Stress Disorder score for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition at baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 80. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Outcome measures
| Measure |
Sham
n=26 Participants
The stimulators are the same device for the active and sham treatment conditions.
Placebo: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=31 in sham group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
Active
n=28 Participants
The stimulators are the same device for the active and sham treatment conditions.
Trigeminal Nerve Stimulation: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=29 in active group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
|---|---|---|
|
Treatment Efficacy as Measured by Change in Clinician-Administered Post Traumatic Stress Disorder Score for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition(DSM-V) at Baseline and Week 8 Visit
Baseline
|
50.60 score on a scale
Standard Deviation 6.83
|
50.10 score on a scale
Standard Deviation 7.77
|
|
Treatment Efficacy as Measured by Change in Clinician-Administered Post Traumatic Stress Disorder Score for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition(DSM-V) at Baseline and Week 8 Visit
Week 8
|
28.29 score on a scale
Standard Deviation 14.74
|
28.61 score on a scale
Standard Deviation 12.99
|
SECONDARY outcome
Timeframe: 8 weeks ((Baseline visit and Week 8 visit)Population: Discrepancy in subjects randomized and subjects analyzed reflect the number of subjects who were randomized but discontinued intervention prior to reaching an evaluable time point.
Secondary outcome measures will be the change in Beck Depression Inventory-II scores from Baseline to Week 8. This is a 21-item scale with maximum and minimum scores ranging from 0 to 63. Higher scores indicate a worse outcome and lower scores indicate a better outcome. For examination of change scores, baseline represents the scores at the time of the second baseline visit (immediately prior to the start of treatment). The endpoint for comparison to baseline will be the week 8 time point or the last non-missing observation during the double-blind treatment.
Outcome measures
| Measure |
Sham
n=26 Participants
The stimulators are the same device for the active and sham treatment conditions.
Placebo: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=31 in sham group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
Active
n=28 Participants
The stimulators are the same device for the active and sham treatment conditions.
Trigeminal Nerve Stimulation: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=29 in active group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
|---|---|---|
|
Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores.
Baseline
|
28.29 score on a scale
Standard Deviation 9.41
|
28.31 score on a scale
Standard Deviation 9.43
|
|
Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores.
Week 8
|
15.36 score on a scale
Standard Deviation 9.28
|
15.78 score on a scale
Standard Deviation 12.55
|
Adverse Events
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham
n=31 participants at risk
The stimulators are the same device for the active and sham treatment conditions.
Placebo: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
Active
n=29 participants at risk
The stimulators are the same device for the active and sham treatment conditions.
Trigeminal Nerve Stimulation: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/31 • Adverse event data was collected each weekly assessment visit for every participant, up to 8 weeks
Serious Adverse events remain at zero as the research treatment administered in this study is categorized as minimal risk and non-significant risk. This indicates an inherent lack of risk for death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, a congenital anomaly/birth defect, or all-cause mortality.
|
3.4%
1/29 • Number of events 1 • Adverse event data was collected each weekly assessment visit for every participant, up to 8 weeks
Serious Adverse events remain at zero as the research treatment administered in this study is categorized as minimal risk and non-significant risk. This indicates an inherent lack of risk for death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, a congenital anomaly/birth defect, or all-cause mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place