Neuropathic Pain
Conditions
Keywords
neurostimulation, video enhanced consent, neuromodulation, transcutaneous auricular vagus nerve stimulation, transcranial direct current stimulation, transcranial magnetic stimulation
Brief summary
The purpose of this study is to: 1. Development of culturally sensitive videos for enhance informed consent with neurostimulation and determination of factors that influence minority interest in participating in neurostimulation research. 2. Examination of the influence that video enhanced informed consent has on expectations with transcutaneous auricular vagus nerve stimulation (taVNS) and on treatment intended effects.
Interventions
OTHERtaVNS 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.
OTHEREducational 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.
OTHERTMS 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.
Sponsors
National Center of Neuromodulation for Rehabilitation
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. between the ages of 18-80 years 2. neuropathic pain lasting longer than 3 months (i.e., complaint of sensation of burning, stabbing or pressing pain, shooting or shock like pain, or paresthesias) 3. Neuropathic Pain Symptom Inventory score ≥10. 4. self identifies as Black or Hispanic
Exclusion criteria
1. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia) 2. pregnancy 3. currently taking Buprenorphine or recently stopped taking (within 1 month) 4. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews 5. implants in the head or neck, cochlear implants, or pacemaker 6. head or neck metastasis or recent ear trauma 7. history of seizures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Expectation for Pain Relief as Measured by EXPECT Scores | Baseline, and up to 90 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability (HRV) | Baseline, up to 90 minutes | HRV will be measured with an H10 chest strap device measured in milliseconds (SDRR). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Transcranial Magnetic Stimulation (TMS) Group | Total | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group |
|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 7.5 | 58.6 years STANDARD_DEVIATION 9.4 | 58.2 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 18 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Female | 11 Participants | 20 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Change Expectation for Pain Relief as Measured by EXPECT Scores
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.
Time frame: Baseline, and up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group | Change Expectation for Pain Relief as Measured by EXPECT Scores | 0.19 score on a scale | Standard Deviation 1.16 |
| Transcranial Magnetic Stimulation (TMS) Group | Change Expectation for Pain Relief as Measured by EXPECT Scores | 0.28 score on a scale | Standard Deviation 1.08 |
Secondary
Change in Heart Rate Variability (HRV)
HRV will be measured with an H10 chest strap device measured in milliseconds (SDRR).
Time frame: Baseline, up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group | Change in Heart Rate Variability (HRV) | 0.42 Milliseconds | Standard Deviation 9.73 |
| Transcranial Magnetic Stimulation (TMS) Group | Change in Heart Rate Variability (HRV) | -0.37 Milliseconds | Standard Deviation 12.89 |