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

University of Miami

Status: Completed

Conditions: Neuropathic Pain

Treatments: Other: TMS Video; Other: Educational materials; Other: taVNS Video

Study type: Interventional

Funder types: Other

Identifiers

NCT05896202

20230154

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group

Experimental group

Description:

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

Treatment:

Other: Educational materials

Other: taVNS Video

Transcranial Magnetic Stimulation (TMS) group

Active Comparator group

Description:

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

Treatment:

Other: Educational materials

Other: TMS Video