Back to resultsAddressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
Primary Purpose
Neuropathic Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
taVNS Video
Educational materials
TMS Video
Sponsored by
About this trial
This is an interventional other trial for Neuropathic Pain focused on measuring neurostimulation, video enhanced consent, neuromodulation, transcutaneous auricular vagus nerve stimulation, transcranial direct current stimulation, transcranial magnetic stimulation
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group
Transcranial Magnetic Stimulation (TMS) group
Arm Description
This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.
This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
Outcomes
Primary Outcome Measures
Change in Heart Rate Variability (HRV)
HRV will be measured with an H10 chest strap device measured in milliseconds.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05896202
First Posted
May 31, 2023
Last Updated
August 14, 2023
Sponsor
University of Miami
Collaborators
National Center of Neuromodulation for Rehabilitation
1. Study Identification
Unique Protocol Identification Number
NCT05896202
Brief Title
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
Official Title
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Center of Neuromodulation for Rehabilitation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to:
Development of culturally sensitive videos for enhance informed consent with neurostimulation and determination of factors that influence minority interest in participating in neurostimulation research.
Examination of the influence that video enhanced informed consent has on expectations with transcutaneous auricular vagus nerve stimulation (taVNS) and on treatment intended effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
neurostimulation, video enhanced consent, neuromodulation, transcutaneous auricular vagus nerve stimulation, transcranial direct current stimulation, transcranial magnetic stimulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group
Arm Type
Experimental
Arm Description
This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.
Arm Title
Transcranial Magnetic Stimulation (TMS) group
Arm Type
Active Comparator
Arm Description
This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
Intervention Type
Other
Intervention Name(s)
taVNS Video
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational materials
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
TMS Video
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Heart Rate Variability (HRV)
Description
HRV will be measured with an H10 chest strap device measured in milliseconds.
Time Frame
Baseline, up to 90 minutes
Secondary Outcome Measure Information:
Title
Change in expectations for pain relief as measured by EXPECT scores
Description
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.
Time Frame
Baseline, and up to 90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marlon Wong
Phone
13052842670
Email
mwong2@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Bolanos
Phone
305-243-9195
Email
j.bolanos2@umiami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlon Wong
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
We'll reach out to this number within 24 hrs