Nerve PainNCT03596489
Objective Assessment of Sensory Nerve Fiber Sensitivity
An observational study of Nerve Pain, run by Julia Finkel at 1 site in United States.
Trial summary
This pilot study utilizes a unique technology to determine nerve fiber sensitivity. This will allow us to determine whether this method and device can discern changes in pain intensity and type, which is predicated on differing nerve fiber sensitivities. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Pain
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2018to 11 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Adult Volunteers will be from within the Children's National Medical Center and the surrounding community.
Who may be able to join
- The subject is 18 to 65 years of age
- The subject is willing to have a tourniquet applied as part of the study
- The subject is willing and able to provide written informed consent to the study participation
- The subject is willing and able to comply with all study procedures
Who cannot join
- Eye pathology precluding pupillometry
- Subjects who have ongoing pain requiring medical attention
- Subjects who are not normotensive
- Subjects with peripheral vascular disease
- Subjects who are morbidly obese (BMI >40)
- Subjects with diabetes or diabetic retinopathy
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- Subjects who are or may be pregnant
- Subjects with cardiac disease
- Subjects with neuropathic disease states
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Official title: Developing a Method to Objectively Assess Sensory Nerve Fiber Sensitivity: A Pilot Study
This pilot study utilizes a unique technology to determine nerve fiber sensitivity. This will allow us to determine whether this method and device can discern changes in pain intensity and type, which is predicated on differing nerve fiber sensitivities.
- Conditions
- Nerve Pain
- Medical subject headings
- Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary Reflex Parameters
The primary measurable endpoint is the change in the Area Under the Curve (AUC) of the three sensory nerve fiber types that occurs as a response to tourniquet ischemia and reperfusion. The change is calculated by the difference between measurements at various time points: baseline, tourniquet application, and tourniquet release.
Measured: 0,5,10,15,20,25,30,35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start27 Jun 2018
- Primary completion1 Jul 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julia Finkel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julia Finkel, Children's National Research Institute
- Investigators
- Julia C Finkel, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596489
- Sponsor's protocol ID
- 10134
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2018
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Method to Objectively Assess Sensory Nerve Fiber Sensitivity: A Pilot Study
- ClinicalTrials.gov ID
- NCT03596489
- Acronym / sponsor ID
- 10134
- Conditions
- Nerve Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Julia FinkelUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study utilizes a unique technology to determine nerve fiber sensitivity. This will allow us to determine whether this method and device can discern changes in pain intensity and type, which is predicated on differing nerve fiber sensitivities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Adult Volunteers will be from within the Children's National Medical Center and the surrounding community.
Key inclusion criteria (4 listed)
- The subject is 18 to 65 years of age
- The subject is willing to have a tourniquet applied as part of the study
- The subject is willing and able to provide written informed consent to the study participation
- The subject is willing and able to comply with all study procedures
Key exclusion criteria (9 listed)
- Eye pathology precluding pupillometry
- Subjects who have ongoing pain requiring medical attention
- Subjects who are not normotensive
- Subjects with peripheral vascular disease
- Subjects who are morbidly obese (BMI >40)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pupillary Reflex Parameters
Time frame: 0,5,10,15,20,25,30,35 minutes
The primary measurable endpoint is the change in the Area Under the Curve (AUC) of the three sensory nerve fiber types that occurs as a response to tourniquet ischemia and reperfusion. The change is calculated by the difference between measurements at various time points: baseline, tourniquet application, and tourniquet release.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
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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.
Julia C Finkel, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve Pain, run by Julia Finkel 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 9 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 5 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pupillary Reflex Parameters (time frame: 0,5,10,15,20,25,30,35 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.