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RECRUITING
NCT04786977

Physiologic Measure of VIPN

Sponsor: Children's National Research Institute

View on ClinicalTrials.gov

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.

Official title: Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2021-09-20

Completion Date

2027-05-01

Last Updated

2026-04-06

Healthy Volunteers

Yes

Interventions

OTHER

No Intervention, Observational Study

No Intervention

Locations (1)

Children's National Health System

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