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Objective Assessment of Sensory Nerve Fiber Sensitivity

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ClinicalTrials.gov Identifier: NCT03596489
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Julia Finkel, Children's National Research Institute

Brief 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.

Condition or disease
Nerve Pain

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing a Method to Objectively Assess Sensory Nerve Fiber Sensitivity: A Pilot Study
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Adult Volunteers will be from within the Children's National Medical Center and the surrounding community.
Criteria

Inclusion Criteria:

  1. The subject is 18 to 65 years of age
  2. The subject is willing to have a tourniquet applied as part of the study
  3. The subject is willing and able to provide written informed consent to the study participation
  4. The subject is willing and able to comply with all study procedures

Exclusion Criteria:

  1. Eye pathology precluding pupillometry
  2. Subjects who have ongoing pain requiring medical attention
  3. Subjects who are not normotensive
  4. Subjects with peripheral vascular disease
  5. Subjects who are morbidly obese (BMI >40)
  6. Subjects with diabetes or diabetic retinopathy
  7. Subjects who are or may be pregnant
  8. Subjects with cardiac disease
  9. Subjects with neuropathic disease states

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596489


Contacts
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Contact: Julia C Finkel, MD 2024764867 jcfinkel@childrensnational.org

Locations
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United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Julia C Finkel, MD       jcfinkel@cnmc.org   
Principal Investigator: Julia C Finkel, MD         
Sponsors and Collaborators
Julia Finkel
Investigators
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Principal Investigator: Julia C Finkel, MD Children's National Health System
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Responsible Party: Julia Finkel, Principal Investigator, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT03596489    
Other Study ID Numbers: 10134
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations