Objective Assessment of Sensory Nerve Fiber Sensitivity | NCT03596489

Studies
Objective Assessment of Sensory Nerve Fiber Sensitivity

NCT03596489

Sponsor

Julia Finkel

Status

Completed

Last Update Posted

Jul 5, 2024Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Nerve Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 27, 2018Actual

Primary Completion Date

Jul 1, 2023Actual

Completion Date

Jul 11, 2023Actual

First Submitted Date

Jul 12, 2018

First Submission Date that Met QC Criteria

Jul 12, 2018

First Posted Date

Jul 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2024

Last Update Posted Date

Jul 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	0,5,10,15,20,25,30,35 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Subjects who are or may be pregnant
Subjects with cardiac disease
Subjects with neuropathic disease states

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy Adult Volunteers will be from within the Children's National Medical Center and the surrounding community.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julia C Finkel, MD	Children's National Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Health System		Washington D.C.	District of Columbia	20010	United States

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided