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OpenTrials
Completed

NCT Number: NCT05896202

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

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33176, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

taVNS Video

Other

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

Other

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

Other

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.

Primary outcomes

  1. 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

  1. Change in Heart Rate Variability (HRV)

    Time frame: Baseline, up to 90 minutes

    HRV will be measured with an H10 chest strap device measured in milliseconds (SDRR).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Center of Neuromodulation for Rehabilitation

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2023
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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