Trial Outcomes & Findings for rTMS for PTSD Comorbid With Major Depressive Disorder (NCT NCT02273063)
NCT ID: NCT02273063
Last Updated: 2018-10-04
Results Overview
This self-report scale is called: "PTSD Checklist for DSM-5" (abbreviated PCL-5) (see https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp). Total PCL-5 score ranges from 0 to 80. Analysis of treatment effect on symptom severity will be evaluated by change in PCL-5 total score from baseline (pre-TMS) to endpoint (post-TMS)(or LOCF); Paired t-test compares the mean total PCL-score for the group at the two time points. A higher total score on the PCL-5 scale corresponds with more severe PTSD symptoms than a lower total score. A greater change from baseline to endpoint would correspond with better treatment outcome.
COMPLETED
NA
40 participants
Baseline to final TMS session (up to 40 sessions over up to 8 weeks)
2018-10-04
Participant Flow
Participant milestones
| Measure |
TMS Prescription
5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000
Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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35
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
rTMS for PTSD Comorbid With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
TMS Prescription
n=35 Participants
5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000
Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
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|---|---|
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Age, Continuous
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51.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
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21 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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33 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Multiracial
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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35 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline to final TMS session (up to 40 sessions over up to 8 weeks)Population: intent-to-treat population
This self-report scale is called: "PTSD Checklist for DSM-5" (abbreviated PCL-5) (see https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp). Total PCL-5 score ranges from 0 to 80. Analysis of treatment effect on symptom severity will be evaluated by change in PCL-5 total score from baseline (pre-TMS) to endpoint (post-TMS)(or LOCF); Paired t-test compares the mean total PCL-score for the group at the two time points. A higher total score on the PCL-5 scale corresponds with more severe PTSD symptoms than a lower total score. A greater change from baseline to endpoint would correspond with better treatment outcome.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=35 Participants
TMS 5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000
Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
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|---|---|
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Total Score on PTSD Checklist for DSM-5 (PCL-5)
BASELINE
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52.2 units on a scale
Standard Deviation 13.1
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Total Score on PTSD Checklist for DSM-5 (PCL-5)
ENDPOINT
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34.0 units on a scale
Standard Deviation 21.6
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PRIMARY outcome
Timeframe: Baseline to final TMS session (up to 40 sessions over up to 8 weeks)Population: intent-to-treat population
This self-report scale is called "Inventory of Depressive Symptomatology, Self-Report" (Abbreviated IDS-SR). IDS-SR Total Scores Range from 0 to 84, with a higher score reflecting greater depressive symptom severity. Paired t-test compares the change in mean total IDS-SR score from baseline (pre-TMS) to endpoint (last TMS session) or LOCF. A greater change reflects a better outcome than lesser change.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=35 Participants
TMS 5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000
Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
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|---|---|
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Total Score on Inventory of Depressive Symptomatology, Self-Report (IDS-SR) Scale
BASELINE
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47.8 units on a scale
Standard Deviation 11.9
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Total Score on Inventory of Depressive Symptomatology, Self-Report (IDS-SR) Scale
ENDPOINT
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30.9 units on a scale
Standard Deviation 18.9
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Adverse Events
TMS Prescription
Serious adverse events
| Measure |
TMS Prescription
n=35 participants at risk
5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000
Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
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Psychiatric disorders
Psychiatric Hospitalization
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11.4%
4/35 • Number of events 4 • baseline to endpoint (week 10 or LOCF).
Adverse event data collected through (1) Response of participants to queries by study clinicians during treatment sessions and during study-specific assessment visits (2) spontaneous reports initiated by participants.
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Other adverse events
| Measure |
TMS Prescription
n=35 participants at risk
5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000
Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
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Nervous system disorders
migraine
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2.9%
1/35 • Number of events 1 • baseline to endpoint (week 10 or LOCF).
Adverse event data collected through (1) Response of participants to queries by study clinicians during treatment sessions and during study-specific assessment visits (2) spontaneous reports initiated by participants.
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Psychiatric disorders
Activation/insomnia/irritability
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40.0%
14/35 • Number of events 14 • baseline to endpoint (week 10 or LOCF).
Adverse event data collected through (1) Response of participants to queries by study clinicians during treatment sessions and during study-specific assessment visits (2) spontaneous reports initiated by participants.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place