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Physiologic Measure of VIPN

Children's National Research Institute · NCT04786977

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–18 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
40
US sites recruiting
1
Study start
September 20, 2021
Record last updated
July 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: No Intervention, Observational Study

Conditions: Chemotherapy-induced Peripheral Neuropathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Children's National Health System

    Washington D.C., DC 20010

    Site contact: Julia C Finkel, MD · (202)476-4867 · jfinkel@cnmc.org

All neurology studies in District of Columbia →
Physiologic Measure of VIPN (NCT04786977) | Bored Studies