Detection and Characterization of Neurologic Manifestations of Inborn and Acquired Errors of Immunity

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06169150
Status
Recruiting
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Conditions

  • Immune System Disease
  • Nervous System Disease

Eligibility Criteria

Sex
ALL
Age
2 Years - 120 Years
Healthy Volunteers
Accepted

Study Details

Background: Immune system and nervous system have significant interaction so that People with immunity diseases can have complications that affect the nervous system and people with some neurological disease may have defects in their immune system.These complications can affect many body functions, including how they move, walk, think, and feel. Researchers do not fully understand how immune diseases affect the nervous system. By learning more, they hope to create more effective treatments. Objective: To learn more about the interaction between immune and nervous system and how immunity disease affect the nervous system. Eligibility: People aged 2 years and older with an immunity disease. Their healthy biological relatives and other healthy volunteers are also needed. Design: Participants will be screened. Blood will be drawn for research. They may have imaging scans. Adults may undergo lumbar puncture: A needle will be inserted into their back to collect fluid from the space around the spinal cord. The imaging scans and lumbar puncture will be optional for healthy relatives and volunteers. All participants will have 1 study visit per year for 5 years. They will be asked to donate samples of body fluids at each visit. Blood samples are required for the study. All other donations are optional. These may include saliva, urine, breast milk, stool, vaginal secretions, and wound drainage. Affected participants may be asked for a skin biopsy: A small sample of skin will be removed. They may also be photographed or videotaped to record the symptoms of their disease. Tests for each study visit may be spread over several days, if needed. Visits may be at the clinic. Participants may also collect their own samples at home and send them to the researchers....

Key Dates

Start date
Jan 12, 2024
Status verified
Sep 2025
Primary completion
Jan 1, 2043
Completion
Oct 1, 2043

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Healthy Controls
    Biological relatives or unrelated persons without a known diagnosis of neuroinfectious disease or neuroinflammation.
  • Arm: Primary or acquired immunodeficiency
    Known or suspected infection or inflammation of the nervous system or post infection sequelae, or is at risk of developing such a neurologic complication.

Primary Outcome Measure

Clinical characterization of neurologic manifestations in participants with recognized and unrecognized errors of immunity based on neurologic examination, neuroimaging, and other necessary neurologic tests depending on clinical presentation. [ Time Frame: Through end of participation. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Farinaz Safavi, MD
[email protected]
240-627-3828
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
(800) 411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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