Trial Outcomes & Findings for Improving Functions in MTBI Patients With Headache by rTMS (NCT NCT01948947)
NCT ID: NCT01948947
Last Updated: 2018-03-26
Results Overview
The primary outcome time-point measurement will be averaged from each day the subject is enrolled in the study for each of the 3 time point periods: pre-treatment baseline, 1-week follow-up and 1-month follow-up. The results depict change in the composite score: intensity (scale of 0-10) x duration (# of hours) x frequency (# headaches per week). The larger composite score for each subject, the worse the debilitating headaches.
COMPLETED
NA
29 participants
Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
2018-03-26
Participant Flow
Participant milestones
| Measure |
Transcranial Magnetic Stimulation
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
|
Sham Transcranial Magnetic Stimulation
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Functions in MTBI Patients With Headache by rTMS
Baseline characteristics by cohort
| Measure |
Transcranial Magnetic Stimulation
n=14 Participants
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
|
Sham Transcranial Magnetic Stimulation
n=15 Participants
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.13 years
STANDARD_DEVIATION 9.39 • n=99 Participants
|
34.43 years
STANDARD_DEVIATION 7.66 • n=107 Participants
|
35.28 years
STANDARD_DEVIATION 8.52 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.The primary outcome time-point measurement will be averaged from each day the subject is enrolled in the study for each of the 3 time point periods: pre-treatment baseline, 1-week follow-up and 1-month follow-up. The results depict change in the composite score: intensity (scale of 0-10) x duration (# of hours) x frequency (# headaches per week). The larger composite score for each subject, the worse the debilitating headaches.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=14 Participants
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
|
Sham Transcranial Magnetic Stimulation
n=15 Participants
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
|---|---|---|
|
Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
1-Week Follow-Up
|
-55.3 percent change from baseline
Standard Deviation 29.0
|
-1.7 percent change from baseline
Standard Deviation 41.2
|
|
Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
1-Month Follow-Up
|
-58.4 percent change from baseline
Standard Deviation 24.4
|
-10 percent change from baseline
Standard Deviation 59.9
|
PRIMARY outcome
Timeframe: Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.The persistent headache measure was assessed through a daily headache log over the course of the subjects participation in the study and averaged for the time point period of baseline, 1-week and 1-month results. The persistent headache is based on a scale of 0-10, the higher the persistent headache intensity averaged score the worse the persistent headache.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=14 Participants
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
|
Sham Transcranial Magnetic Stimulation
n=15 Participants
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
|---|---|---|
|
Percent Change in Persistent Headache Intensity
1-Week Follow-Up
|
-25.3 percent change from baseline
Standard Deviation 16.8
|
-1.0 percent change from baseline
Standard Deviation 11.7
|
|
Percent Change in Persistent Headache Intensity
1-Month Follow-Up
|
-22.6 percent change from baseline
Standard Deviation 17.7
|
-2.3 percent change from baseline
Standard Deviation 14.5
|
PRIMARY outcome
Timeframe: Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured.The persistent headache prevalence measure was assessed through a daily headache log over the course of the subjects participation in the study and collected at baseline, 1-week and 1-month. The persistent headache is defined as having had 3+ continuous headaches over the course of the time point periods and was coded as either yes or no. The results indicate the percent change in the prevalence of persistent headaches for the subjects at the time points. A larger reduction percent indicates a larger decrease in subjects with those persistent headaches.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=14 Participants
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
|
Sham Transcranial Magnetic Stimulation
n=15 Participants
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
|---|---|---|
|
Percent Change in Persistent Headache Prevalence
1-Week Follow-Up
|
-50 percent change from baseline
Standard Deviation 51
|
-7 percent change from baseline
Standard Deviation 26
|
|
Percent Change in Persistent Headache Prevalence
1-Month Follow-Up
|
-57 percent change from baseline
Standard Deviation 52
|
-20 percent change from baseline
Standard Deviation 41
|
SECONDARY outcome
Timeframe: Subjects will have a total of 9 visits over the span of 3 months and 3 of those visits will qualify as a time point at which outcome is measured.Subjects assessed how their headaches interfered with their mood through the Hamilton Rating Scale for Depression assessment at baseline, 1-week follow-up and 1-month follow-up. The outcome was measured by adding the score of each question on the assessment and then comparing the averaged scores at the different time points. The larger the depression score, the more severe the depression. A larger percent change in depression score indicates a change in the severity of the depression.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=14 Participants
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
|
Sham Transcranial Magnetic Stimulation
n=15 Participants
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
|---|---|---|
|
Percent Change in Depression Score From Baseline to 1-Week Post-treatment
|
-14.8 percent change in score from baseline
Standard Deviation 22.1
|
-2.7 percent change in score from baseline
Standard Deviation 40.3
|
Adverse Events
Transcranial Magnetic Stimulation
Sham Transcranial Magnetic Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Valerie Metzger Smith, Study Coordinator
VA San Diego Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place