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

University of Miami28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Neuropathic Pain

Interventions

taVNS VideoOTHER

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 materialsOTHER

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 VideoOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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