Neuropathic PainNCT05896202
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
A study testing taVNS Video, Educational materials and TMS Video in people with Neuropathic Pain, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- taVNS Video, Educational materials and TMS Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 19 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neuropathic Pain
- Being tested
- taVNS Video, Educational materials, TMS Video
- Keywords
- neurostimulation, video enhanced consent, neuromodulation, transcutaneous auricular vagus nerve stimulation, transcranial direct current stimulation, transcranial magnetic stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNS VideoOther
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 materialsOther
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 VideoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group | Experimental | This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours. Receives: Other: taVNS Video; Other: Educational materials |
| Transcranial Magnetic Stimulation (TMS) group | Active comparator | This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours. Receives: Other: Educational materials; Other: TMS Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Expectation 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. Scores from all 4 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater expectations for pain relief.
Measured: Baseline, and up to 90 minutes
Secondary outcomes (1)
Change in Heart Rate Variability (HRV)
HRV will be measured with an H10 chest strap device measured in milliseconds (SDRR).
Measured: Baseline, up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start15 Jan 2024
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Neuromodulation for Rehabilitation
- Responsible party
- Principal investigator, Marlon Wong, University of Miami
- Investigators
- Marlon Wong, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896202
- Sponsor's protocol ID
- 20230154
- Status last verified
- Oct 2025
- First submitted
- 31 May 2023
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong ML, Widerstrom-Noga E, Bolanos JL, Gonzalez G, Penedo FJ, Hosein PJ, Tovin MM, Gonzalez JP, McTeague LM. Feasibility of trancutaneous auricular vagus nerve stimulation in Black and Hispanic/Latino people with peripheral neuropathy. Front Pain Res (Lausanne). 2025 Jan 17;5:1516196. doi: 10.3389/fpain.2024.1516196. eCollection 2024.
PubMed 39896735
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
- ClinicalTrials.gov ID
- NCT05896202
- Acronym / sponsor ID
- 20230154
- Conditions
- Neuropathic Pain
- Keywords
- neurostimulation, video enhanced consent, neuromodulation, transcutaneous auricular vagus nerve stimulation, transcranial direct current stimulation, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Center of Neuromodulation for Rehabilitation
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group | Experimental | Other: taVNS Video, Other: Educational materialsThis group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours. |
| Transcranial Magnetic Stimulation (TMS) group | Active comparator | Other: Educational materials, Other: TMS VideoThis group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNS VideoOne 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 | Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group |
| Educational materialsParticipants 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. | Other | Transcranial Magnetic Stimulation (TMS) group, Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group |
| TMS VideoOne 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. | Other | Transcranial Magnetic Stimulation (TMS) group |
Primary outcome
Change Expectation for Pain Relief as Measured by EXPECT Scores
Time frame: 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. Scores from all 4 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater expectations for pain relief.
1 secondary outcome
Change in Heart Rate Variability (HRV)
Time frame: Baseline, up to 90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39896735Wong ML, Widerstrom-Noga E, Bolanos JL, Gonzalez G, Penedo FJ, Hosein PJ, Tovin MM, Gonzalez JP, McTeague LM. Feasibility of trancutaneous auricular vagus nerve stimulation in Black and Hispanic/Latino people with peripheral neuropathy. Front Pain Res (Lausanne). 2025 Jan 17;5:1516196. doi: 10.3389/fpain.2024.1516196. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlon Wong principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS Video, Educational materials and TMS Video in people with Neuropathic Pain, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Expectation for Pain Relief as Measured by EXPECT Scores (time frame: Baseline, and up to 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05896202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.