跳至主要内容
临床试验/NCT06615622
NCT06615622招募中不适用

A Comparative Study of Peripheral Nerve Ultrasound Findings in Immune Mediated Peripheral Nerve Disorders; a Hospital-based Study

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Detection of Nerve Alterations via Ultrasound

研究概览

简要总结

Neuromuscular ultrasound (NMUS) is emerging as a valuable non-invasive diagnostic tool. In GBS, NMUS can detect proximal nerve enlargement early, before neurophysiological changes. Persistent nerve enlargement can be observed up to 15 years, though its correlation with disability varies. Research is needed to clarify NMUS findings in GBS and CIDP over time. Early detection of nerve root enlargement via NMUS could facilitate earlier diagnosis and intervention, improving patient outcomes and understanding of these conditions' pathophysiology.

This study aims to determine if nerve alterations in acute GBS and CIDP detectable by ultrasound match electrodiagnostic findings and if this method aids early diagnosis. The investigators will perform serial nerve ultrasounds and NCS to investigate nerve morphology, predict outcomes, and differentiate between axonal and demyelinating subtypes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of patient group:
  • GBS Patients: Diagnosed according to the criteria of the National Institute of Neurological Disorders and Stroke (NINDS) and the Brighton Collaboration (2011).
  • CIDP Patients: Diagnosed according to the criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS).
  • Age: Participants aged 18 to 75 years.
  • GBS Patients: Recent onset of GBS within the first 2 weeks of symptom onset.
  • CIDP Patients: Either relapsing or progressive course consistent with CIDP diagnosis.
  • Gender: Both male and female participants are eligible.
  • Participation: Willingness to participate in the study, including undergoing disease-related examinations and assessments.
  • Consent: Ability and willingness to provide informed consent

排除标准

  • Patients unable or unwilling to provide informed consent.
  • Patients with metabolic disorders or malignancies.
  • Patients with other causes of peripheral neuropathy.
  • Patients with other causes of acute flaccid paralysis.

结局指标

主要结局

Detection of Nerve Alterations via Ultrasound

时间窗: 6 months

* Determine if patients with acute GBS and CIDP exhibit nerve alterations detectable by ultrasound that are comparable to electrodiagnostic findings. * Assess the utility of ultrasound in diagnosing GBS and CIDP in the very early phase of the disease.

次要结局

  • Evaluation of Nerve Morphology Evolution(6 months)
  • Prediction of Outcomes and Recovery(6 months)
  • Differentiation of Subtypes(6 months)
  • Correlation with Clinical Scales(6 months)
  • Comparison with Healthy Controls(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Gad Ibrahim Farghly

Principal Investigator

Assiut University

研究点 (1)

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