Physiologic Measure of VIPN
Recruiting now
Conditions studied: Chemotherapy-induced Peripheral Neuropathy
In brief
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.
Key facts
- Study ID
- NCT04786977
- Run by
- Children's National Research Institute
- People needed
- 40
- Starts
- 2021-09-20
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 6 and older, up to 18. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.
Where it is running
- Children's National Health System — Washington D.C., District of Columbia, United States (enrolling)
Full record on ClinicalTrials.gov
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