Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change Expectation for Pain Relief as Measured by EXPECT Scores
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥
- •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)
- •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.
Arms & Interventions
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.
Intervention: taVNS Video (Other)
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.
Intervention: Educational materials (Other)
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.
Intervention: Educational materials (Other)
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.
Intervention: TMS Video (Other)
Outcomes
Primary Outcomes
Change Expectation for Pain Relief as Measured by EXPECT Scores
Time Frame: 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 Outcomes
- Change in Heart Rate Variability (HRV)(Baseline, up to 90 minutes)
Investigators
Marlon Wong
Associate Professor of Clinical Physical Therapy
University of Miami