Physiologic Measure of VIPN

Last updated: July 2, 2025
Sponsor: Children's National Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

No Intervention, Observational Study

Clinical Study ID

NCT04786977
Pro00015693
  • Ages 6-18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 6-18 years of age at the start of the study, are receiving vincristine in DI (clinical study population) and are willing and able to provide informed consent orassent to study participation.

Exclusion

Exclusion Criteria:

  • have eye pathology which precludes pupillometry, are hemodynamically unstable, orare pregnant.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: No Intervention, Observational Study
Phase:
Study Start date:
September 20, 2021
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Children's National Health System

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

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