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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

Tracking Information
First Submitted Date July 12, 2018
First Posted Date July 24, 2018
Last Update Posted Date August 3, 2021
Actual Study Start Date June 27, 2018
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Objective Assessment of Sensory Nerve Fiber Sensitivity
Official Title Developing a Method to Objectively Assess Sensory Nerve Fiber Sensitivity: A Pilot Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy Adult Volunteers will be from within the Children's National Medical Center and the surrounding community.
Condition Nerve Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 12, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Julia C Finkel, MD 2024764867 jcfinkel@childrensnational.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03596489
Other Study ID Numbers 10134
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Julia Finkel, Children's National Research Institute
Study Sponsor Julia Finkel
Collaborators Not Provided
Investigators
Principal Investigator: Julia C Finkel, MD Children's National Health System
PRS Account Children's National Research Institute
Verification Date August 2021