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

NCT05896202 | Completed Results DMC

• 1 other identifier: 20230154
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 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. 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.

Conditions

Neuropathic Pain

Keywords

neurostimulation; video enhanced consent; neuromodulation; transcutaneous auricular vagus nerve stimulation; transcranial direct current stimulation; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, and up to 90 minutes

Secondary Outcomes (1)

• Change in Heart Rate Variability (HRV)

  Baseline, up to 90 minutes

Study Arms (2)

Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group

EXPERIMENTAL

This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.

Other: taVNS Video; Other: Educational materials

Transcranial Magnetic Stimulation (TMS) group

ACTIVE COMPARATOR

This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.

Other: Educational materials; Other: TMS Video

Interventions

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.

Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group

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.

Transcranial Magnetic Stimulation (TMS) group; Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group

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.

Transcranial Magnetic Stimulation (TMS) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Center of Neuromodulation for Rehabilitation: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33176, United States

Location

Related Publications (1)

• Wong ML, Widerstrom-Noga E, Bolanos JL, Gonzalez G, Penedo FJ, Hosein PJ, Tovin MM, Gonzalez JP, McTeague LM. Feasibility of trancutaneous auricular vagus nerve stimulation in Black and Hispanic/Latino people with peripheral neuropathy. Front Pain Res (Lausanne). 2025 Jan 17;5:1516196. doi: 10.3389/fpain.2024.1516196. eCollection 2024.

  PMID: 39896735 DERIVED

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Marlon L. Wong
• Organization: University of Miami

mwong2@miami.edu

3052842670

Study Officials

• Marlon Wong

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Physical Therapy

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: January 15, 2024
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)