# Use of a novel physiologic measure for the assessment and monitoring of vincristine induced peripheral neuropathy (VIPN) in children and adolescents.

> **NIH NIH R43** · ALGOMETRX, INC. · 2022 · $396,711

## Abstract

In this application, we propose the examination of a novel physiologic measure of vincristine-induced
peripheral neuropathy (VIPN) in pediatric patients. Establishment of such a measure will enable the objective
characterization of both the positive and negative symptoms of neuropathy in pediatric patients treated with
vincristine in order to enable early detection and management of the resulting morbidity. Acute lymphoblastic
leukemia (ALL) is the most common childhood cancer but has a 90% 5-year survival rate in children due to
current treatment protocols, of which vincristine is a critical component. Vincristine induces primarily a large
fiber peripheral neuropathy by disrupting microtubule associated axonal transport. Clinically, this manifests as
muscle weakness, loss of reflexes, neuropathic pain and loss of sensation. Clinical assessments and research
of the prevalence and risk factors for vincristine neurotoxicity have been hampered by the differing sensitivities
of neuropathy assessment tools. VIPN often manifests during treatment but can be present for years following
therapy leading to a diminished quality of life. It is therefore imperative to develop a clinical tool to detect VIPN
before the onset of overt symptoms. In this proposal, we define and assess a metric of VIPN, the Neuropathy
Index, informed by a novel technology that can produce an objective assessment of nerve fiber sensitivity. This
technology leverages our transformative finding that an innocuous, transcutaneous neuroselective
electrical stimulus of each sensory nerve fiber type (C, Aδ and Aβ) induces a pupillary dilation (nPRD)
response reflecting the sensitivity of the fiber. The nPRD responses of the three fiber types are compared
to generate a composite index, Neuropathy Index, that will be used for the assessment of VIPN. To accomplish
this, we propose the following aim: Aim 1: Assess the performance of a novel physiologic endpoint, the
Neuropathy Index, for the characterization of nociceptive processing in patients with VIPN. We plan to
enroll 20 patients ages 6y-18y diagnosed with ALL and receiving (or scheduled to receive) vincristine. We plan
to collect data at regular intervals over the course of 8 months, which will allow us to measure different levels
of VIPN severity. Participants will also be evaluated using the TNS©-PV. Using this approach, we plan to apply
the Neuropathy Index (i.e., [AUCAδ-AUCAβ]/AUCC) to the data collected during each testing session. We then
plan to compare the Neuropathy Index to the TNS-PV to determine the relationship between these two
measures. We also plan to assess the reliability of the index via a test/retest paradigm and assess the patient
reported acceptability of our test compared to that of the TNS-PV. Milestone: Demonstration of a
relationship between the Index and the TNS-PV (a correlation of at least 0.7) and of reliability (a test-
retest reliability coefficient of at least 0.58). Ultimately, the technology being deve...

## Key facts

- **NIH application ID:** 10547068
- **Project number:** 1R43CA275524-01
- **Recipient organization:** ALGOMETRX, INC.
- **Principal Investigator:** Julia Cole Finkel
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $396,711
- **Award type:** 1
- **Project period:** 2022-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10547068

## Citation

> US National Institutes of Health, RePORTER application 10547068, Use of a novel physiologic measure for the assessment and monitoring of vincristine induced peripheral neuropathy (VIPN) in children and adolescents. (1R43CA275524-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10547068. Licensed CC0.

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