Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- DTI changes in nerves and muscles
研究概览
简要总结
We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in maintenance treatment with immunoglobulin
详细描述
Chronic inflammatory neuropathies such as chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) can be successfully treated with immunoglobulin either intravenously (IVIG) or subcutaneously (SCIG).
CIDP is diagnosed by electrophysiology which is time-consuming and unpleasant for the patient.
New techniques suggest that Magnetic Resonance Imaging (MRI) and ultrasound imaging can be used to detect injuries in the peripheral nerves
We want to study if MRI and ultrasound is able to detect damages in peripheral nerves, nerve roots and plexus in patients with CIDP.
Moreover, we want to compare these findings to healthy matched controls and to see if treatment with immunoglobulin changes findings in MRI
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CIDP patients
- •Age > 18 and < 80 years
- •Diagnosed with definite and probable CIDP and fulfilling the European Federation of Neurological Sciences/Peripheral Nerve Society (EFNS/PNS) criteria
- •Healthy controls
- •Age > 18 and < 80 years
- •No neurological disorders
排除标准
- •Age < 18 or > 80 years
- •Contraindications to MRI
- •Pregnancy
- •Other cause of neuropathy (incl. pressure neuropathy)
- •Diabetes mellitus
结局指标
主要结局
DTI changes in nerves and muscles
时间窗: At enrolment
Diffusion Tension Imaging (DTI) in peripheral nerves and muscles in the lower extremities in CIDP patients treated with SCIG will be compared to healthy controls
次要结局
- Comparing clinical findings to MRI(At enrolment)
- Changes in MRI findings between treated and untreated CIDP patients(All patients are examined at enrolment. Untreated patients are re-examined after 4 months of treatment)