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

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05896202
• Collaborator: National Center of Neuromodulation for Rehabilitation (Other)
• Enrollment: 24
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain	Other: taVNS Video; Other: Educational materials; Other: TMS Video; Other: tDCS Video	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group This group will receive a supplemental video on taVNS. Participants will be in this group for approximately 5 hours.	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.; Other: Educational materials; Participants will receive sample consent forms and brochures for taVNS, TMS, and tDCS. 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.
Active Comparator: Transcranial Magnetic Stimulation (TMS) group This group will receive a supplemental video on TMS. Participants will be in this group for approximately 5 hours.	Other: Educational materials; Participants will receive sample consent forms and brochures for taVNS, TMS, and tDCS. 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.; Other: 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.
Active Comparator: Transcranial Direct Current Stimulation (tDCS) group This group will receive a supplemental video on tDCS. Participants will be in this group for approximately 5 hours.	Other: Educational materials; Participants will receive sample consent forms and brochures for taVNS, TMS, and tDCS. 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.; Other: tDCS Video; One third of the participants will see the tDCS 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33176

Sponsors and Collaborators

• University of Miami
• National Center of Neuromodulation for Rehabilitation

Investigators

• Principal Investigator: Marlon Wong, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marlon Wong, Associate Professor of Clinical Physical Therapy, University of Miami
• ClinicalTrials.gov Identifier: NCT05896202
• Other Study ID Numbers: 20230154
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marlon Wong, Associate Professor of Clinical Physical Therapy, University of Miami: neurostimulation; video enhanced consent; neuromodulation; transcutaneous auricular vagus nerve stimulation; transcranial direct current stimulation; transcranial magnetic stimulation
• Additional relevant MeSH terms: Neuralgia

Study Results

No Results Posted as of Jun 9, 2023