N/A N=28 Randomized Other

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

Neuropathic Pain

Bottom Line

View on ClinicalTrials.gov: NCT05896202 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Change Expectation for Pain Relief as Measured by EXPECT Scores — 0.19; 0.28 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: taVNS Video (Other); Educational materials (Other); TMS Video (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change Expectation for Pain Relief as Measured by EXPECT Scores	0.19; 0.28	—
SECONDARY Change in Heart Rate Variability (HRV)	0.42; -0.37	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05896202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.