Actively Recruiting

Age: 6Years - 18Years
All Genders
Healthy Volunteers
NCT04786977

Physiologic Measure of VIPN

Led by Children's National Research Institute · Updated on 2026-04-06

40

Participants Needed

1

Research Sites

292 weeks

Total Duration

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AI-Summary

What this Trial Is About

The purpose of this study is the development of a physiologic endpoint using a novel technology that would provide an objective, easy to use and more sensitive assessment of VIPN in children and adolescents. The ability to more easily detect and monitor VIPN, even before it is clinically evident, would facilitate optimizing the dosing of vincristine for maximal disease response while minimizing the risk of lifelong functional deficits affecting quality of life. This approach would also enable the development of specific therapies to minimize or eliminate the occurrence of VIPN in children and adolescents. This is a single site study that aims to develop a novel device to evaluate and characterize vincristine-induced neuropathic pain. The investigators will enroll patients with ALL following the Delayed Intensification (DI) phase of treatment. At each study visit, the investigators will evaluate the nPRD as well as the TNS-PV. The nPRD will inform the neuropathy index which will be used to compare to the TNS-PV. We anticipate a correlation between the two.

CONDITIONS

Official Title

Physiologic Measure of VIPN

Who Can Participate

Age: 6Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 6 and 18 years old at the start of the study
  • Currently receiving vincristine chemotherapy during the Delayed Intensification phase
  • Willing and able to provide informed consent or assent to participate
Not Eligible

You will not qualify if you...

  • Have an eye condition that prevents using pupillometry
  • Are hemodynamically unstable
  • Are pregnant

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Trial Site Locations

Total: 1 location

1

Children's National Health System

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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