Trial Outcomes & Findings for Neuromodulatory Treatments for Pain Management in TBI (NCT NCT03418129)
NCT ID: NCT03418129
Last Updated: 2023-07-27
Results Overview
Measured by the Defense and Veterans Pain Rating Scale (DVPRS), a graphic tool to facilitate self-reported pain rating using a scale from 0-10, 0 being "no pain" to 10 being "as bad as it could be, nothing else matters."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
254 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Mobile App Mindfulness
Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mindfulness: Neuromodulatory intervention for pain management
|
Mobile App Neurofeedback
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Neurofeedback: Neuromodulatory intervention for pain management
|
Mobile App Relaxation
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Relaxation: Neuromodulatory intervention for pain management
|
|---|---|---|---|
|
Overall Study
STARTED
|
84
|
85
|
85
|
|
Overall Study
COMPLETED
|
70
|
59
|
66
|
|
Overall Study
NOT COMPLETED
|
14
|
26
|
19
|
Reasons for withdrawal
| Measure |
Mobile App Mindfulness
Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mindfulness: Neuromodulatory intervention for pain management
|
Mobile App Neurofeedback
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Neurofeedback: Neuromodulatory intervention for pain management
|
Mobile App Relaxation
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Relaxation: Neuromodulatory intervention for pain management
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
20
|
15
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
4
|
Baseline Characteristics
Neuromodulatory Treatments for Pain Management in TBI
Baseline characteristics by cohort
| Measure |
Mobile App Mindfulness
n=84 Participants
Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mindfulness: Neuromodulatory intervention for pain management
|
Mobile App Neurofeedback
n=85 Participants
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Neurofeedback: Neuromodulatory intervention for pain management
|
Mobile App Relaxation
n=85 Participants
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Relaxation: Neuromodulatory intervention for pain management
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.45 years
STANDARD_DEVIATION 8.78 • n=93 Participants
|
41.99 years
STANDARD_DEVIATION 9.27 • n=4 Participants
|
40.69 years
STANDARD_DEVIATION 8.63 • n=27 Participants
|
41.38 years
STANDARD_DEVIATION 8.88 • n=483 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
50 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
204 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
196 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
186 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
84 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
254 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who completed the DVPRS at 0 and 12 weeks.
Measured by the Defense and Veterans Pain Rating Scale (DVPRS), a graphic tool to facilitate self-reported pain rating using a scale from 0-10, 0 being "no pain" to 10 being "as bad as it could be, nothing else matters."
Outcome measures
| Measure |
Mobile App Mindfulness
n=75 Participants
Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mindfulness: Neuromodulatory intervention for pain management
|
Mobile App Neurofeedback
n=68 Participants
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Neurofeedback: Neuromodulatory intervention for pain management
|
Mobile App Relaxation
n=76 Participants
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Relaxation: Neuromodulatory intervention for pain management
|
|---|---|---|---|
|
Change in Self-reported Pain Intensity
|
-1.02 score on a scale
Standard Deviation 1.32
|
-0.78 score on a scale
Standard Deviation 1.27
|
-1.03 score on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 0 and 12 weeksPopulation: EEG measurement was discontinued in March 2020 due to the COVID pandemic. Data not collected on 127 participants.
Average FFT (Fast Fourier Transform) Power (alpha 8-12 Hz) measured as sqrt(uV)/Hz.
Outcome measures
| Measure |
Mobile App Mindfulness
n=41 Participants
Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mindfulness: Neuromodulatory intervention for pain management
|
Mobile App Neurofeedback
n=43 Participants
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Neurofeedback: Neuromodulatory intervention for pain management
|
Mobile App Relaxation
n=43 Participants
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Relaxation: Neuromodulatory intervention for pain management
|
|---|---|---|---|
|
Change in EEG Alpha Power
|
-0.21 sqrt(uV)/Hz
Standard Deviation 0.40
|
-0.1 sqrt(uV)/Hz
Standard Deviation 0.41
|
-0.07 sqrt(uV)/Hz
Standard Deviation 0.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Participants who completed the DVPRS at baseline, 12 weeks, and 24 weeks.
Measured by the Defense and Veterans Pain Rating Scale (DVPRS), a graphic tool to facilitate self-reported pain rating using a scale from 0-10, 0 being "no pain" to 10 being "as bad as it could be, nothing else matters." This mean difference represents the mean change in pain intensity between 0 and 24 weeks. Please note that the analysis of results utilized a multilevel modeling (MLM) approach of all available data, which involved analyzing pain intensity data collected at 0, 12, and 24 weeks.
Outcome measures
| Measure |
Mobile App Mindfulness
n=71 Participants
Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mindfulness: Neuromodulatory intervention for pain management
|
Mobile App Neurofeedback
n=58 Participants
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Neurofeedback: Neuromodulatory intervention for pain management
|
Mobile App Relaxation
n=63 Participants
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Relaxation: Neuromodulatory intervention for pain management
|
|---|---|---|---|
|
Change in Self-reported Pain Intensity
|
-1.22 score on a scale
Standard Deviation 1.73
|
-0.98 score on a scale
Standard Deviation 1.36
|
-0.86 score on a scale
Standard Deviation 1.56
|
Adverse Events
Mobile App Mindfulness
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Mobile App Neurofeedback
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Mobile App Relaxation
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mobile App Mindfulness
n=84 participants at risk
Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mindfulness: Neuromodulatory intervention for pain management
|
Mobile App Neurofeedback
n=85 participants at risk
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Neurofeedback: Neuromodulatory intervention for pain management
|
Mobile App Relaxation
n=85 participants at risk
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Relaxation: Neuromodulatory intervention for pain management
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
1.2%
1/84 • 24 weeks
|
0.00%
0/85 • 24 weeks
|
0.00%
0/85 • 24 weeks
|
|
General disorders
Anxiety
|
1.2%
1/84 • 24 weeks
|
0.00%
0/85 • 24 weeks
|
1.2%
1/85 • 24 weeks
|
|
General disorders
Dizziness
|
1.2%
1/84 • 24 weeks
|
0.00%
0/85 • 24 weeks
|
0.00%
0/85 • 24 weeks
|
|
General disorders
Headaches
|
2.4%
2/84 • 24 weeks
|
3.5%
3/85 • 24 weeks
|
1.2%
1/85 • 24 weeks
|
|
Blood and lymphatic system disorders
Blood Clot
|
0.00%
0/84 • 24 weeks
|
1.2%
1/85 • 24 weeks
|
0.00%
0/85 • 24 weeks
|
|
General disorders
Hospitalization
|
0.00%
0/84 • 24 weeks
|
1.2%
1/85 • 24 weeks
|
1.2%
1/85 • 24 weeks
|
|
General disorders
Suicidality
|
0.00%
0/84 • 24 weeks
|
1.2%
1/85 • 24 weeks
|
0.00%
0/85 • 24 weeks
|
Other adverse events
| Measure |
Mobile App Mindfulness
n=84 participants at risk
Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mindfulness: Neuromodulatory intervention for pain management
|
Mobile App Neurofeedback
n=85 participants at risk
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Neurofeedback: Neuromodulatory intervention for pain management
|
Mobile App Relaxation
n=85 participants at risk
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Relaxation: Neuromodulatory intervention for pain management
|
|---|---|---|---|
|
General disorders
Drowsiness
|
23.8%
20/84 • 24 weeks
|
20.0%
17/85 • 24 weeks
|
18.8%
16/85 • 24 weeks
|
|
General disorders
Irritability
|
2.4%
2/84 • 24 weeks
|
15.3%
13/85 • 24 weeks
|
15.3%
13/85 • 24 weeks
|
|
General disorders
Suicidal Ideation
|
2.4%
2/84 • 24 weeks
|
1.2%
1/85 • 24 weeks
|
10.6%
9/85 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place