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

NCT06169150 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-09-25

No results posted yet for this study

Summary

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....

Conditions

  • Nervous System Disease
  • Immune System Disease

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Farinaz Safavi, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
2 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2043-01-01
Completion
2043-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06169150 on ClinicalTrials.gov