"Clinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
研究概览
简要总结
The aim of this study is to quantify the effect of IVIG treatment in a group of patients with chronic inflammatory demyelinating polyradiculoneuropathy(CIDP), who requires continues treatment of IVIG at regular intervals of 3-10 weeks:
- During continues treatment of IVIG at regular intervals of 3-10 weeks.
- During pause in treatment.
Hypothesis:
- The disease activity in the patients are cyclical correlating to the treatment intervals.
- Pause in treatment will increase disease activity, which can be quantified with symptom scores, disability scales, and clinical test.
Primary effect parameter is muscle strength quantified by isokinetic dynamometry.
Added to the protocol there is an immunological study of inflammatory markers in blood samples of patients under treatment pause.
详细描述
Background: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare autoimmune disease of the peripheral nervous system characterized by demyelination of the nerves, which causes muscle weakness and sensory loss. Treatment is immune modulating, and intravenous immunoglobulin (IVIG) is first line therapy.Several trials have demonstrated effect on motor function by the initial treatment, but the effect of consecutive IVIG treatment is only sporadic described in the literature.
It is a clinical study including present CIDP patients in treatment at the University Hospital of Aarhus. The patients will be evaluated several times before and after IVIG treatment, to describe the effect profile.
The primary effect parameter is muscle strength quantified by isokinetic dynamometry at ankle knee, hip, wrist, elbow and shoulder. That is a sensitive method of measuring the strength of the larger muscle groups, correlating with symptoms and signs of neuropathy.
Severity of neuropathy among the patients will also be described applying nerve conduction studies, quantitative sensory testing of threshold for detecting vibration and cold at upper and lower limbs, the Neuropathy Disability Scale, the Neuropathy Symptom Score,the overall disability sum score, 9 hole peg test, walking test, and the Short-form 36 health questionnaire.
Added to the protocol there is an immunological study of inflammatory markers in blood samples of patients under treatment pause.
研究设计
- 研究类型
- Observational
- 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
- •Motor and sensory dysfunction involving more than one limb.
- •Electrodiagnostic study with signs of demyelination
排除标准
- •Prior systemic allergic reaction to IVIG
- •Severe systemic disease
- •Other conditions associated with neuropathy (eg diabetes, lack of vitamin- B12)
- •Pregnancy
