Clinical Trial: sCD163 as a Potential Biomarker in Guillain- Barré Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: sCD163 as a Potential Biomarker in Guillain- Barré Syndrome
Brief Summary:
Guillain- Barré syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy (AIDP) that often is triggered by an infection. GBS is characterized by progressing weakness and numbness and loss of tendon of reflexes. It can also include tingling sensation in the legs and arms. These symptoms occur due to an autoimmune attack on the myelin resulting in demyelination.
The diagnosis is given by electrophysiological examination and clinical presentation.
GBS is treated with intravenous immunoglobulin (IVIG) and plasma exchange (PE). Both treatments are equally effective. Most patients recover completely, while others must ease symptoms and reduce the duration of illness by several treatments.
The purpose of this study is to define if patients with GBS have higher concentrations of sCD163 in their cerebrospinal fluid and serum compared with symptomatic control subjects. Furthermore it is to define if the concentrations of sCD163 reduces after treatment.
Detailed Summary:
Guillain- Barré syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy (AIDP) that often is triggered by an infection. GBS is characterized by progressing weakness and numbness and loss of tendon reflexes. It can also include tingling sensation in the legs and arms. These symptoms occur due to an autoimmune attack on the myelin resulting in demyelination. The diagnosis is given by electrophysiological examination and clinical presentation. GBS is treated with intravenous immunoglobulin (IVIG) or plasma exchange (PE). The specific mechanism is not fully understood, but it is believed that the antibodies produced against the myelin, is eliminated to avoid further damage to the peripheral nerves. IVIG is slightly safer and easier to give than PE. However, both treatments are equally effective. They both need to be given during the first few weeks of symptoms.
Most patients recover completely, while others must ease symptoms and reduce the duration of illness by several treatments. Moreover, the initial phase of GBS is followed by a long recovery period where intensive neurorehabilitation is important. Some people will not recover completely from GBS and experience long-term complications such as not being able to walk unaided, loss of sensation causing lack of coordination and balance. It is estimated around 20% of people with GBS still experience some muscle weakness after three years. Some may also have persistent fatigue. In rare cases, complications can be life threatening, particularly in the acute phase.
GBS is one of the neurological emergencies, where patients need to be examined closely during the initial acute phase of the illness. Many studies have been performed to elucidate the mechanism of neuropathy in Guillain Barré syndrome but treatment remains disappointing. There are findings of aut
Sponsor: University of Aarhus
Current Primary Outcome: Concentration of sCD163 in patients with GBS [ Time Frame: Day 1 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Concentration of sCD163 in patients with GBS after treatment [ Time Frame: Week 4 ]
Original Secondary Outcome: Same as current
Information By: University of Aarhus
Dates:
Date Received: October 19, 2015
Date Started: September 2015
Date Completion: January 2018
Last Updated: October 21, 2015
Last Verified: October 2015
