Sydenham Chorea | Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea
Sydenham Chorea research study
What is the primary objective of this study?
Children are at risk of developing an involuntary movement disorder after streptococcal throat infections. Not all children are affected and the severity is individually variable. Affected children have alteration in their behaviour and mood and can become quite compromised in their activities of daily living. The condition is believed to be related to the body having an over efficient immune response to the infection and some of the antibodies made in response to the infection also \"attack\" centres in the brain controlling movement and mood. Treating these children with immunoglobulins, which \"mop up\" the antibodies may reverse or improve affected children. This study hopes to clarify this.
Who is eligible to participate?
Inclusion Criteria: - Sydenham chorea moderate to severe (affecting activities of daily living) Raised ASOT titre Exclusion Criteria: - Mild Sydenham chorea (not affecting activities of daily living) - Exclusion of systemic lupus erythematosus - Exclusion of Wilson's disease - Exclusion of toxin ingestion
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Post Streptococcal Movement Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:Intravenous immunoglobulinintravenous immunoglobulin 2g/kg total given over 2 days
Drug:standard interventions penicillin VK and haloperidolPenicillin V K 500mg 12hrly po or 250mg 6 hrly for 10 days IM penicillin to be given at discharge, 1.2 million units if over 30 KG and 600,000 units if weight less than 30 KG haloperidol 0,025mg/kg/day orally in divided doses gradually increasing to a maximum of 0,05mg/kg/day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1Group randomized to receive intravenous immunoglobulins in addition to standard therapy for sydenham's chorea
2Group randomized to receive standard intervention for sydenham's chorea alone
Start Date: May 2002
Completed Date: December 2009
Primary Outcome: improved scores on the sydenham chorea assessment charts
Secondary Outcome: improved quality of life
Study sponsors, principal investigator, and references
Principal Investigator: Kathleen Walker, MB ChB
Lead Sponsor: University of Cape Town
Collaborator: Natal Bioproducts Institute
Perlmutter SJ, Leitman SF, Garvey MA, Hamburger S, Feldman E, Leonard HL, Swedo SE. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet. 1999 Oct 2;354(9185):1153-8.