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

Not Applicable

Completed

• Conditions: Neuropathic Pain
• Interventions: Other: Educational materials; Other: taVNS Video; Other: TMS Video

• Registration Number: NCT05896202
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Study Start: 2024-01-15
• Primary Completion: 2024-07-19
• Study Completion: 2024-07-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial Magnetic Stimulation (TMS) group	Educational materials	This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
Transcranial Magnetic Stimulation (TMS) group	TMS Video	This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group	taVNS Video	This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.
Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group	Educational materials	This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.

Primary Outcome Measures

Name	Time	Method
Change in Heart Rate Variability (HRV)	Baseline, up to 90 minutes	HRV will be measured with an H10 chest strap device measured in milliseconds.

Secondary Outcome Measures

Name	Time	Method
Change in expectations for pain relief as measured by EXPECT scores	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States