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Physiologic Measure of VIPN

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

Who can join

Ages 6 to 18 · All sexes · Healthy volunteers welcome

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 or assent to study participation.

Exclusion Criteria:

* have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.

About the study

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.

What is being tested

• No Intervention, Observational Study (other)

Sponsor: Children's National Research Institute · Participants: 40 · Started: Sep 20, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04786977

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.