Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities

Study Overview
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Brief Summary
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The purpose of this study is to: Development of culturally sensitive videos for enhance informed consent with neurostimulation and determination of factors that influence minority interest in participating in neurostimulation research. Examination of the influence that video enhanced informed consent has on expectations with transcutaneous auricular vagus nerve stimulation (taVNS) and on treatment intended effects.

Official Title
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Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Other: taVNS Video
* Other: Educational materials
* Other: TMS Video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between the ages of 18-80 years 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) Neuropathic Pain Symptom Inventory score ≥10. self identifies as Black or Hispanic Exclusion Criteria: any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia) pregnancy currently taking Buprenorphine or recently stopped taking (within 1 month) presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews implants in the head or neck, cochlear implants, or pacemaker head or neck metastasis or recent ear trauma history of seizures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group<br>This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours. | Other: taVNS Video<br>* 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.<br>Other: Educational materials<br>* 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.<br>|
| Active Comparator: Transcranial Magnetic Stimulation (TMS) group<br>This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours. | Other: Educational materials<br>* 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.<br>Other: TMS Video<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heart Rate Variability (HRV) | HRV will be measured with an H10 chest strap device measured in milliseconds. | Baseline, up to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in expectations 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. | Baseline, and up to 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurostimulation, video enhanced consent, neuromodulation, transcutaneous auricular vagus nerve stimulation, transcranial direct current stimulation, transcranial magnetic stimulation