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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896202
• Other study ID #: 20230154
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Marlon Wong
• Phone: 13052842670
• Email: mwong2[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Other:
• taVNS Video
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
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
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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Center of Neuromodulation for Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Heart Rate Variability (HRV)	HRV will be measured with an H10 chest strap device measured in milliseconds.	Baseline, up to 90 minutes
Secondary	Change in expectations 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.	Baseline, and up to 90 minutes