Dopaminergic Receptors in Sydenham's Chorea

NCT04084977 | Unknown

• 1 other identifier: 139/14
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sydenham's chorea (SC) is a post-streptococcal, neuropsychiatric disorder associated with anti-neuronal antibodies. The investigators demonstrated elevated anti-D1-receptor (D1R) and anti-D2-receptor (D2R) antibodies titers compared to controls using ELISA. Similarly, the investigators found antibodies to surface D2R in neuropsychiatric, autoimmune disorders, including SC using cell-based assays. The investigators hypothesize that these autoantibodies cause neuropsychiatric symptoms by inducing intracellular signaling changes resulting in altered dopaminergic neurotransmission. To check this, the investigators will test whether sera from patients with SC alter dopaminergic signaling pathways. The investigators will examine sera from 30 SC patients with active symptoms and 30 age-matched healthy controls. Patients with SC will be assessed for severity of neuropsychiatric symptoms using UFMG Sydenham's Chorea Rating Scale. Controls with evidence of streptococcal infections or autoimmune disorders will be excluded. Sera will be examined for anti-D1R and anti-D2R antibodies. Signaling studies will assess sera impact on 1) calcium/calmodulin-dependent protein kinase II activity in human neuronal cells. 2) dopamine D1/D2 receptors signaling using cAMP assays in transfected cell lines. The investigators will examine the correlation between modified signaling and clinical symptoms.

Conditions

Sydenham Chorea; Strep Throat

Outcome Measures

Primary Outcomes (2)

• Antibody titers

  titer levels of anti dopamine receptors (anti-D1 and anti-D2) using ELISA (titer levels are expresed as dilutions i.e. 1:400)

  Once at time of initial visit within the first 4 months from onset

• UFMG Sydenham's Chorea Rating Scale

  the mean value of the 21 item of clinical chorea rating. Ranging from 0 (=none) to 4 (=severe) for each item

  Upon presentation when symptomatic, usually within 4 months of onset

Study Arms (3)

Sydenam Chorea (SC)

individuals with SC

Diagnostic Test: Antibody detection

tonsilitis

children with tonsilitis in the past 3 months

Diagnostic Test: Antibody detection

control

children wit no tonsilitis

Diagnostic Test: Antibody detection

Interventions

Antibody detection DIAGNOSTIC_TEST

detecting anti bodies against D1, D2 receptor, tubolin Lysoganglioside

Sydenam Chorea (SC); control; tonsilitis

Eligibility Criteria

• Age: 2 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

sydenhams chorea according to clinical parameters

You may qualify if:

• sydenham chora OR strep tonsilitiscontrol without strep tonsilitis OR

You may not qualify if:

• neurological disrder autoimmune disorder

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead
• University of Oklahoma: collaborator

Study Sites (1)

Shaare Zedek Medical center

Jerusalem, 91031, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sera

MeSH Terms

Conditions

Chorea

Condition Hierarchy (Ancestors)

Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: September 10, 2019
• Study Start: July 1, 2016
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2021
• Last Updated: September 10, 2019

Record last verified: 2019-08

Locations

IL (1)