Trial Outcomes & Findings for Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities (NCT NCT05896202)
NCT ID: NCT05896202
Last Updated: 2025-10-27
Results Overview
The Expectations for Complementary and Alternative Medicine Treatments (EXPECT) is a 4-item questionnaire that assesses expectations for pain improvement. Each of the 4 items is scored on an 11-point scale, with 0 being no change and 10 representing complete relief (scores ranging from 0-10). Higher scores represent greater expectations for pain relief. Scores from all 4 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater expectations for pain relief.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Baseline, and up to 90 minutes
Results posted on
2025-10-27
Participant Flow
Participant milestones
| Measure |
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group
This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.
taVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
|
Transcranial Magnetic Stimulation (TMS) Group
This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
TMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group
This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.
taVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
|
Transcranial Magnetic Stimulation (TMS) Group
This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
TMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
Baseline characteristics by cohort
| Measure |
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group
n=14 Participants
This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.
taVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
|
Transcranial Magnetic Stimulation (TMS) Group
n=14 Participants
This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
TMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 11.3 • n=39 Participants
|
59.0 years
STANDARD_DEVIATION 7.5 • n=41 Participants
|
58.6 years
STANDARD_DEVIATION 9.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, and up to 90 minutesThe Expectations for Complementary and Alternative Medicine Treatments (EXPECT) is a 4-item questionnaire that assesses expectations for pain improvement. Each of the 4 items is scored on an 11-point scale, with 0 being no change and 10 representing complete relief (scores ranging from 0-10). Higher scores represent greater expectations for pain relief. Scores from all 4 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater expectations for pain relief.
Outcome measures
| Measure |
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group
n=12 Participants
This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.
taVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
|
Transcranial Magnetic Stimulation (TMS) Group
n=12 Participants
This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
TMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
|
|---|---|---|
|
Change Expectation for Pain Relief as Measured by EXPECT Scores
|
0.19 score on a scale
Standard Deviation 1.16
|
0.28 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Baseline, up to 90 minutesHRV will be measured with an H10 chest strap device measured in milliseconds (SDRR).
Outcome measures
| Measure |
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group
n=11 Participants
This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.
taVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
|
Transcranial Magnetic Stimulation (TMS) Group
n=11 Participants
This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.
TMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.
|
|---|---|---|
|
Change in Heart Rate Variability (HRV)
|
0.42 Milliseconds
Standard Deviation 9.73
|
-0.37 Milliseconds
Standard Deviation 12.89
|
Adverse Events
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transcranial Magnetic Stimulation (TMS) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place