Trial Outcomes & Findings for Study Testing if Fast or Slow rTMS is Better for the Treatment of Posttraumatic Stress Disorder (PTSD) (NCT NCT02158663)
NCT ID: NCT02158663
Last Updated: 2020-04-27
Results Overview
Standard administration and scoring of the CAPS-5 are essential for producing reliable and valid scores and diagnostic decisions. Clinical-Administered Post Traumatic -DSM-5 (CAPS-5) 30 items, score ranging from 0-50. CAPS-5 symptom severity ratings are based on symptom frequency and intensity. Intensity rating of Minimal corresponds to a severity rating of Mild/subthreshold, Clearly Present corresponds with Moderate/threshold, Pronounced corresponds with Severe/markedly elevated, and Extreme corresponds with Extreme/ incapacitating. Administered at baseline and after 30 rTMS treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Baseline and after 30 rTMS Treatments (approximately 6 weeks)
Results posted on
2020-04-27
Participant Flow
Veterans suffering from PTSD with and without depressive symptoms will be recruited from the community as well as from the mental health clinics at the James A. Haley VAH.
After enrollment, participants were excluded before assignment failed to meet diagnostic criteria of the CAPS-5. One enrollee had an history of seizure and for another the motor threshold could not be found.
Participant milestones
| Measure |
Right Slow Prefrontal rTMS
Low frequency 1 Hz group TMS Device:
1 Hz rTMS will be continuous treatment at 110% MT for 40 minutes for a total of 2400 pulses. There are encouraging reports of success using rTMS to treat PTSD symptoms with both fast (greater than 1 Hz) and slow (1 Hz or less) frequency treatments. One unanswered question is whether fast or slow treatments result in a better outcome. This difference in response may be mediated through the moderator of the presence of depressive symptoms. Also, the tolerability of the two treatment parameters may be significantly different. . For those randomized to 1 Hz frequency, the 1 Hz rTMS will be continuous for 40 minutes for a total of 2400 pulses.
|
Right Fast Prefrontal rTMS
Prefrontal high frequency 10Hz rTMS
The right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS will provide a significantly (two-sided, p ≤ 0.05) greater improvement in depressive symptoms as measured by change in QIDS score..
Research Design: Randomized single-blind (raters) prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.
The 10 Hz rTMS will be 4 seconds on and 36 seconds off at 110% MT for 40 minutes for a total of 2400 pulses. Cohen et al. 2004 (n=24) reported that 10 Hz significantly improved PTSD symptoms over the right prefrontal cortex compared to sham.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Right Slow Prefrontal rTMS
Low frequency 1 Hz group TMS Device:
1 Hz rTMS will be continuous treatment at 110% MT for 40 minutes for a total of 2400 pulses. There are encouraging reports of success using rTMS to treat PTSD symptoms with both fast (greater than 1 Hz) and slow (1 Hz or less) frequency treatments. One unanswered question is whether fast or slow treatments result in a better outcome. This difference in response may be mediated through the moderator of the presence of depressive symptoms. Also, the tolerability of the two treatment parameters may be significantly different. . For those randomized to 1 Hz frequency, the 1 Hz rTMS will be continuous for 40 minutes for a total of 2400 pulses.
|
Right Fast Prefrontal rTMS
Prefrontal high frequency 10Hz rTMS
The right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS will provide a significantly (two-sided, p ≤ 0.05) greater improvement in depressive symptoms as measured by change in QIDS score..
Research Design: Randomized single-blind (raters) prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.
The 10 Hz rTMS will be 4 seconds on and 36 seconds off at 110% MT for 40 minutes for a total of 2400 pulses. Cohen et al. 2004 (n=24) reported that 10 Hz significantly improved PTSD symptoms over the right prefrontal cortex compared to sham.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
Baseline Characteristics
Study Testing if Fast or Slow rTMS is Better for the Treatment of Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Right Slow Prefrontal rTMS
n=17 Participants
For those randomized to 1 Hz frequency, the 1 Hz rTMS was continuous for 40 minutes for a total of 2400 pulses/session.
The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. Testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS is better tolerated as measured by participant drop out and side effect profiles.
|
Right Fast Prefrontal rTMS
n=18 Participants
For those randomized to 10 Hz, rTMS was 4 seconds on and 36 seconds off for 40 minutes for a total of 2400 pulses/session.
The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. Testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS is better tolerated as measured by participant drop out and side effect profiles.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
39 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 6.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 30 rTMS Treatments (approximately 6 weeks)Population: There were 44 participants enrolled 35 participants randomized: 22 participants enrolled for 1 Hz group, 5 did not meet randomization/diagnostic criteria. 17 1 Hz participants analyzed showing lower score is better. 22 participants enrolled for 10 Hz group. 4 did not meet randomization/diagnostic criteria. 18 10 Hz participant analyzed.
Standard administration and scoring of the CAPS-5 are essential for producing reliable and valid scores and diagnostic decisions. Clinical-Administered Post Traumatic -DSM-5 (CAPS-5) 30 items, score ranging from 0-50. CAPS-5 symptom severity ratings are based on symptom frequency and intensity. Intensity rating of Minimal corresponds to a severity rating of Mild/subthreshold, Clearly Present corresponds with Moderate/threshold, Pronounced corresponds with Severe/markedly elevated, and Extreme corresponds with Extreme/ incapacitating. Administered at baseline and after 30 rTMS treatment.
Outcome measures
| Measure |
Right Slow Prefrontal rTMS
n=17 Participants
Test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score.
Secondary objectives include: one, testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; and three, testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS is better tolerated as measured by participant drop out and side effect profiles.
|
Right Fast Prefrontal rTMS
n=18 Participants
Right prefrontal high frequency 10 Hz rTMS; prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD symptoms using the CAPS measure score..
|
|---|---|---|
|
Change Clinical-Administered Post Traumatic - DSM-5
|
-9.4 score on a scale
Standard Deviation 14.5
|
-10.9 score on a scale
Standard Deviation 11.7
|
PRIMARY outcome
Timeframe: Baseline and after 30 rTMS Treatments (approximately 6 weeks)Population: There were 44 participants enrolled 35 participants randomized: 22 participants enrolled for 1 Hz group, 5 did not meet randomization/diagnostic criteria. 17 1 Hz participants analyzed showing lower score is better. 22 participants enrolled for 10 Hz group. 4 did not meet randomization/diagnostic criteria. 18 10 Hz participant analyzed.
Change Inventory of Psychosocial Functioning (IPF) Administered at baseline and after 30 rTMS treatments. The IPF is an 80 question self-report scale that assessed function in the areas of family, work,friendships and socializing, parenting, education, self-care, and romantic relationships with spouse or partner. The rate is based on how often participant acted over the past 30 days. Domains are averaged with resulting score range 1 - 7. 1 Never - 7 Always.
Outcome measures
| Measure |
Right Slow Prefrontal rTMS
n=17 Participants
Test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score.
Secondary objectives include: one, testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; and three, testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS is better tolerated as measured by participant drop out and side effect profiles.
|
Right Fast Prefrontal rTMS
n=18 Participants
Right prefrontal high frequency 10 Hz rTMS; prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD symptoms using the CAPS measure score..
|
|---|---|---|
|
Change in IPF: Inventory of Psychosocial Functioning
|
-0.40 score on a scale
Standard Deviation 0.77
|
-0.50 score on a scale
Standard Deviation 0.58
|
Adverse Events
Right Slow Prefrontal rTMS
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Right Fast Prefrontal rTMS
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Right Slow Prefrontal rTMS
n=17 participants at risk
Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: TMS Device
|
Right Fast Prefrontal rTMS
n=18 participants at risk
Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: TMS Device
|
|---|---|---|
|
Psychiatric disorders
Serious Adverse Event
|
5.9%
1/17 • Number of events 1 • 9 weeks of treatment and at 3-month post treatment evaluation
|
5.6%
1/18 • Number of events 1 • 9 weeks of treatment and at 3-month post treatment evaluation
|
Other adverse events
| Measure |
Right Slow Prefrontal rTMS
n=17 participants at risk
Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: TMS Device
|
Right Fast Prefrontal rTMS
n=18 participants at risk
Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: TMS Device
|
|---|---|---|
|
Nervous system disorders
Headache
|
52.9%
9/17 • Number of events 56 • 9 weeks of treatment and at 3-month post treatment evaluation
|
55.6%
10/18 • Number of events 32 • 9 weeks of treatment and at 3-month post treatment evaluation
|
|
Nervous system disorders
numbing sensation of scalp
|
5.9%
1/17 • Number of events 1 • 9 weeks of treatment and at 3-month post treatment evaluation
|
0.00%
0/18 • 9 weeks of treatment and at 3-month post treatment evaluation
|
|
Nervous system disorders
twitching of eye
|
5.9%
1/17 • Number of events 4 • 9 weeks of treatment and at 3-month post treatment evaluation
|
0.00%
0/18 • 9 weeks of treatment and at 3-month post treatment evaluation
|
|
Nervous system disorders
tenderness of head from TMS
|
11.8%
2/17 • Number of events 19 • 9 weeks of treatment and at 3-month post treatment evaluation
|
0.00%
0/18 • 9 weeks of treatment and at 3-month post treatment evaluation
|
|
Psychiatric disorders
psychiatric hospitalization
|
5.9%
1/17 • Number of events 1 • 9 weeks of treatment and at 3-month post treatment evaluation
|
5.6%
1/18 • Number of events 1 • 9 weeks of treatment and at 3-month post treatment evaluation
|
|
Psychiatric disorders
trouble concentrating at work
|
0.00%
0/17 • 9 weeks of treatment and at 3-month post treatment evaluation
|
5.6%
1/18 • Number of events 1 • 9 weeks of treatment and at 3-month post treatment evaluation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place