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Video-based Education for Neuropathic Pain
N/A
Recruiting
Led By Marlon Wong
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Between the ages of 18-80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 90 minutes
Awards & highlights
Study Summary
This trial aims to create culturally sensitive videos to help people understand neurostimulation & how it affects minority groups in research.
Who is the study for?
This trial is for Black or Hispanic individuals aged 18-80 with neuropathic pain lasting over 3 months and a certain level of pain severity. It's not for those with unstable medical conditions, pregnant women, people with cognitive impairments or language barriers, seizure history, specific medication use within the last month, or head/neck implants.Check my eligibility
What is being tested?
The study aims to create culturally sensitive videos to help inform consent in neurostimulation research and assess how these videos affect expectations and outcomes related to transcutaneous auricular vagus nerve stimulation (taVNS) treatment.See study design
What are the potential side effects?
Since this trial focuses on educational materials rather than direct medical interventions like drugs or invasive procedures, it does not list typical side effects. However, taVNS can sometimes cause mild discomfort at the site of application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been experiencing nerve pain for more than 3 months.
Select...
I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 90 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 90 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Heart Rate Variability (HRV)
Secondary outcome measures
Change in expectations for pain relief as measured by EXPECT scores
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transcutaneous Auricular Vagus Nerve stimulation (taVNS) groupExperimental Treatment2 Interventions
This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.
Group II: Transcranial Magnetic Stimulation (TMS) groupActive Control2 Interventions
This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.
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Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
410,052 Total Patients Enrolled
3 Trials studying Neuropathic Pain
53 Patients Enrolled for Neuropathic Pain
National Center of Neuromodulation for RehabilitationOTHER
10 Previous Clinical Trials
207 Total Patients Enrolled
Marlon WongPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on Buprenorphine or stopped it within the last month.I do not have any health conditions that worsen with moderate exercise.I have been experiencing nerve pain for more than 3 months.I have difficulty understanding or communicating, which affects my ability to give consent or participate in interviews.You have implants in your head or neck, or a cochlear implant or pacemaker.I have a history of seizures.I am between 18 and 80 years old.You have a score of 10 or higher on a test for neuropathic pain symptoms.I have cancer spread to my head or neck, or recent injury to my ear.
Research Study Groups:
This trial has the following groups:- Group 1: Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group
- Group 2: Transcranial Magnetic Stimulation (TMS) group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to participate in this clinical trial?
"This study is seeking 24 volunteers who have neuropathic pain and are aged between 18-80 years old."
Answered by AI
Is this trial open for enrollment at the present time?
"According to the information listed on clinicaltrials.gov, this study is not currently seeking candidates. It was initially posted in September of 2023 and last amended in May of the same year; however, there are 133 additional trials that are actively recruiting patients right now."
Answered by AI
Does this research include participants who are of a more advanced age?
"To be included in this investigation, participants must fall between 18 and 80 years of age. Separately, there are 6 trials designate for minors and 121 specifically targeting seniors."
Answered by AI
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