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Набор скоро начнётся NCT07725120

Single-Center Study Evaluating the Impact of Age on the Diagnostic Performance of the Sural-to-Radial Sensory Amplitude Ratio in Length-Dependent and Non-Length-Dependent Peripheral Polyneuropathies

— Наблюдательное Polyneuropathies Electromyography Diagnostic Techniques

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Retrospective Medical Record Review.
Кому может быть актуально
Состояния в реестре: Polyneuropathies, Electromyography, Diagnostic Techniques. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Retrospective Single-Center Study Evaluating the Impact of Age on the Diagnostic Performance of the Sural-to-Radial Sensory Amplitude Ratio in Length-Dependent and Non-Length-Dependent Peripheral Polyneuropathies

Обзор

This retrospective single-center observational study will evaluate the impact of age on the diagnostic performance of the sural-to-radial sensory nerve amplitude ratio (SRAR) in patients with length-dependent and non-length-dependent peripheral sensory polyneuropathies. Clinical and electrophysiological data collected during routine care between January 2013 and July 2026 will be analyzed. Diagnostic performance will be assessed using receiver operating characteristic (ROC) curve analysis across predefined age groups to determine whether age-adjusted SRAR thresholds improve the differentiation between the two polyneuropathy phenotypes.

Подробное описание

Peripheral sensory polyneuropathies are commonly classified as length-dependent (LDN) or non-length-dependent (NLDN) based on their clinical and electrophysiological features. This distinction is clinically important because it guides etiological investigations and therapeutic management. The sural-to-radial sensory nerve amplitude ratio (SRAR) is an electrophysiological marker that has been proposed to improve the diagnosis of sensory polyneuropathies and to help differentiate LDN from NLDN. Although the SRAR has traditionally been considered independent of demographic characteristics, recent evidence suggests that it decreases with aging, raising concerns about the use of a single diagnostic threshold across all age groups. The impact of age on the diagnostic performance of the SRAR, particularly in patients with non-length-dependent polyneuropathies, remains poorly characterized. This retrospective single-center study will analyze clinical and electrophysiological data from patients evaluated at the Peripheral Neuromuscular Rare Disease Reference Center of Nice University Hospital between January 2013 and July 2026. The study aims to determine whether age-adjusted SRAR thresholds improve the diagnostic discrimination between length-dependent and non-length-dependent peripheral polyneuropathies.

Вмешательства

  • Другое Retrospective Medical Record Review
    This observational study involves retrospective collection and analysis of routinely acquired clinical and electrophysiological data from approximately 180 patients with sensory polyneuropathy. Data extracted from medical records include demographic characteristics, clinical diagnosis, and nerve conduction study parameters, including sural and radial sensory nerve action potential amplitudes used to calculate the sural/radial amplitude ratio (SRAR). No additional diagnostic procedures, treatment

Первичные конечные точки

  • Diagnostic performance of the sural-to-radial sensory nerve amplitude ratio (SRAR) [Срок оценки: Baseline (retrospective analysis of data collected between January 2013 and July 2026]
Вторичные конечные точки (2)
  • Age-specific optimal SRAR diagnostic thresholds [Срок оценки: Baseline (retrospective analysis)]
  • Comparison of SRAR values between LDN and NLDN [Срок оценки: Baseline (retrospective analysis)]

Критерии участия

Критерии включения

  • Adults aged 18 years or older.
  • Diagnosis of peripheral sensory polyneuropathy.
  • Classification as length-dependent (LDN) or non-length-dependent (NLDN) based on clinical and electrophysiological findings.
  • Available nerve conduction study including sural and radial sensory nerve amplitudes allowing calculation of the SRAR.
  • Evaluated at the Peripheral Neuromuscular Rare Disease Reference Center, Nice University Hospital, between January 2013 and July 2026.

Критерии исключения

  • Missing or incomplete clinical or electrophysiological data preventing SRAR calculation.
  • Unclassifiable neuropathy phenotype.
  • Technical factors affecting the reliability of nerve conduction studies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Франция · 1 центр
  • CHU de Nice — Nice

Идентификаторы

NCT: NCT07725120 · 26Neuro04

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗