Trial Outcomes & Findings for Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (PTSD) (NCT NCT01391832)
NCT ID: NCT01391832
Last Updated: 2024-01-22
Results Overview
The primary outcome measure of treatment efficacy for post-traumatic stress disorder (PTSD) will be change in the Clinician Administered Post-Traumatic Stress Disorder Scale (CAPS) Total Severity Score (i.e., summed across frequency and intensity ratings for the 17 PTSD assessment items) from baseline at 1-month post-treatment. CAPS Total Severity Score ranges from 0 to 136. Difference scores were calculated as the outcome score minus the baseline score, with negative scores indicating a reduction in symptom severity from baseline (i.e., a positive treatment outcome), and differences between treatment groups in change scores were evaluated using t-tests.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
Outcome measures will be measured as change from baseline at 1-, 3-, and 6-month follow-ups
Results posted on
2024-01-22
Participant Flow
Veterans previously deployed to combat regions from 2001 to present (e.g., Operation Enduring Freedom (OEF), Operation Iraq Freedom (OIF), and Operation New Dawn (OND) with current combat-related PTSD symptoms were recruited from the community.
Participant milestones
| Measure |
Sham rTMS
Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)
Repetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been alte
|
Active rTMS
Active Repetitive Transcranial Magnet Stimulation treatment
Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.
Repetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the active mode. After motor threshold determination, the stimulator coil is positioned over the dorsolateral prefrontal cortex - D
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
54
|
|
Overall Study
1 Month Follow-Up
|
30
|
31
|
|
Overall Study
3 Month Follow-Up
|
28
|
29
|
|
Overall Study
COMPLETED
|
28
|
31
|
|
Overall Study
NOT COMPLETED
|
21
|
23
|
Reasons for withdrawal
| Measure |
Sham rTMS
Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)
Repetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been alte
|
Active rTMS
Active Repetitive Transcranial Magnet Stimulation treatment
Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.
Repetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the active mode. After motor threshold determination, the stimulator coil is positioned over the dorsolateral prefrontal cortex - D
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
21
|
22
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Sham rTMS
n=49 Participants
Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)
Repetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.
|
Active rTMS
n=54 Participants
Active Repetitive Transcranial Magnet Stimulation treatment
Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.
Repetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil was be placed over over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46) and stimulation provided at 1 Hz (1.5-2.0 Tesla strength, 100 - 300 microseconds.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.39 years
STANDARD_DEVIATION 6.13 • n=99 Participants
|
32.89 years
STANDARD_DEVIATION 7.60 • n=107 Participants
|
32.65 years
STANDARD_DEVIATION 6.91 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=99 Participants
|
54 participants
n=107 Participants
|
103 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Outcome measures will be measured as change from baseline at 1-, 3-, and 6-month follow-upsPopulation: Veterans previously deployed to combat regions from 2001 to present (e.g., Operation Enduring Freedom (OEF), Operation Iraq Freedom (OIF), and Operation New Dawn (OND)) with current combat-related PTSD symptoms were recruited from the community. 103 were enrolled and randomly assigned to the treatment arms on a parallel 1:1 basis.
The primary outcome measure of treatment efficacy for post-traumatic stress disorder (PTSD) will be change in the Clinician Administered Post-Traumatic Stress Disorder Scale (CAPS) Total Severity Score (i.e., summed across frequency and intensity ratings for the 17 PTSD assessment items) from baseline at 1-month post-treatment. CAPS Total Severity Score ranges from 0 to 136. Difference scores were calculated as the outcome score minus the baseline score, with negative scores indicating a reduction in symptom severity from baseline (i.e., a positive treatment outcome), and differences between treatment groups in change scores were evaluated using t-tests.
Outcome measures
| Measure |
Sham rTMS
n=49 Participants
Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)
The rTMS coil will be placed over the right prefrontal scalp region, simulating targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp.
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered.
|
Active rTMS
n=54 Participants
Active Repetitive Transcranial Magnet Stimulation treatment
Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex The rTMS coil will be placed over the right prefrontal scalp region, targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the active mode. Alternating current turned on and off rapidly produces magnetic pulses (1.5-2.0 Tesla strength) that last for 100 - 300 microseconds (1 HZ at 110% of motor-threshold).
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered.
|
|---|---|---|
|
Change From Baseline to Follow-up in Clinician Administered Post-Traumatic Stress Disorder Scale Total Severity Score
1 month change from baseline
|
-35.59 change in scale score from baseline
Standard Error 4.22
|
-44.164 change in scale score from baseline
Standard Error 3.8226
|
|
Change From Baseline to Follow-up in Clinician Administered Post-Traumatic Stress Disorder Scale Total Severity Score
3 month change from baseline
|
-33.19 change in scale score from baseline
Standard Error 4.24
|
-44.95 change in scale score from baseline
Standard Error 3.85
|
|
Change From Baseline to Follow-up in Clinician Administered Post-Traumatic Stress Disorder Scale Total Severity Score
6 month change from baseline
|
-36.31 change in scale score from baseline
Standard Error 4.24
|
-47.76 change in scale score from baseline
Standard Error 3.82
|
SECONDARY outcome
Timeframe: Outcomes will be assessed at baseline and 6-month follow-upPopulation: Sixty participants (6 female) of the 103 completed the study protocol and returned for 6-month follow-up evaluation; the data from those 60 veterans were analyzed and reported.
The secondary outcome measures will be a) the ERP measures of P3a amplitude for hyperarousal to combat threatening stimuli will be compared from post- to pre-treatment b) the total CAPS scores from pre-treatment and post-treatment will be compared.
Outcome measures
| Measure |
Sham rTMS
n=28 Participants
Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)
The rTMS coil will be placed over the right prefrontal scalp region, simulating targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp.
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered.
|
Active rTMS
n=32 Participants
Active Repetitive Transcranial Magnet Stimulation treatment
Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex The rTMS coil will be placed over the right prefrontal scalp region, targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the active mode. Alternating current turned on and off rapidly produces magnetic pulses (1.5-2.0 Tesla strength) that last for 100 - 300 microseconds (1 HZ at 110% of motor-threshold).
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered.
|
|---|---|---|
|
Changes in ERP/CAPS Cluster Scores Signals From Pre-Treatment to Post-Treatment
|
-1.2754 micro-volts
Standard Deviation 3.095
|
-0.6088 micro-volts
Standard Deviation 2.278
|
Adverse Events
Sham rTMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Active rTMS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham rTMS
n=49 participants at risk
Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)
Repetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.
|
Active rTMS
n=54 participants at risk
Active Repetitive Transcranial Magnet Stimulation treatment
Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex
Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.
Repetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil was be placed over over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46) and stimulation provided at 1 Hz (1.5-2.0 Tesla strength, 100 - 300 microseconds.
|
|---|---|---|
|
General disorders
Headache
|
2.0%
1/49 • Number of events 1 • 10 months
Two participants assigned to receive rTMS and one participant assigned to receive sham rTMS reported headaches and requested termination of the rTMS portion of the therapy.
|
3.7%
2/54 • Number of events 2 • 10 months
Two participants assigned to receive rTMS and one participant assigned to receive sham rTMS reported headaches and requested termination of the rTMS portion of the therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place