이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

신경계의 염증성 및 감염성 질환

신경계의 염증성 및 감염성 질환의 자연사 연구

Background:

- Inflammation is how the body reacts to infection or injury. Infections or inflammation in the brain and nerves can be serious. There aren t always good tests to detect this. Researchers want to learn more about how diseases affect the brain and nerves to develop better tests and treatments.

Objective:

- To learn more about how inflammation and infections hurt the brain and nervous system.

Eligibility:

- People at least 2 years old with a diagnosis or suspected diagnosis of nervous system infection or inflammation.

Design:

  • For some participants, a clinician outside of NIH will collect blood, tissue, and other samples. These will be sent to NIH and analyzed.
  • Other participants will have several visits to NIH. Children may not have all these tests.
  • Participants will have:
  • Medical history.
  • Physical and neurological exam.
  • Blood and urine samples collected.
  • Saliva collected. They will chew on a piece of sterile cotton for one minute.
  • Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will get a contrast agent through an intravenous (IV) catheter during the MRI. A needle will be used to guide a thin plastic tube (catheter) into an arm vein.
  • Lumbar puncture. Skin will be numbed and a needle will be inserted into the space between the bones in the back. Fluid will be removed.
  • Some participants may have optional study procedures. These may include eye tests, memory and thinking testing, tests with electrodes on the head, or skin biopsy.

연구 개요

상태

모병

정황

상세 설명

Objective:

The objective of this study is to examine the natural course of infectious and inflammatory diseases of the nervous system, to identify causative or associated pathogens when unknown, and generally to better understand the underlying immunological, genetic and pathophysiologic mechanisms that cause and contribute to these diseases and their ultimate neurological outcomes.

Study Population:

The study population will be patients at least 2 years old with known or suspected infection or inflammation of the nervous system and family members. Participants will be recruited through referrals to the NIH.

Design:

This is a longitudinal case series with standardized research data collection at predefined time points. Participants will have scheduled visits at the NIH either as an outpatient or an inpatient. The core research evaluations include: a comprehensive history and neurological examination; blood collection; neuroimaging; and lumbar puncture. Follow up visits will be individualized based on clinical needs and results of research evaluations. For some participants, no additional NIH visits will be necessary.

Additionally, we will also enroll participants with known or suspected infections or inflammation of the nervous system from whom only biological samples collected by outside clinicians will be processed and retained for research analyses. In cases were samples remain from those collected for clinical reasons and the samples are deidentified, the samples may be obtained with a waiver of informed consent.

Outcome Measures:

The study outcomes will primarily be the characterizations of varied inflammatory and infectious nervous system diseases. These characterizations will include: the clinical phenotype and biomarkers.

연구 유형

관찰

등록 (추정된)

1000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Maryland
      • Bethesda, Maryland, 미국, 20892
        • 모병
        • National Institutes of Health Clinical Center
        • 연락하다:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • 전화번호: TTY dial 711 800-411-1222
          • 이메일: ccopr@nih.gov

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

2년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Participants will have a known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided.

설명

  • INCLUSION CRITERIA:

At the time of enrollment, participants will:

  1. Have a known or suspected infection or inflammation of the nervous system or post infection sequelae based on clinical or imaging data provided by the referral facility. For the purpose of this study, neuroinfectious disease or neuroinflammation is defined as any of the following:

    1. fever with nervous system signs or symptoms (excluding delirium)
    2. any neurological symptoms accompanied by cerebrospinal fluid (CSF) with evidence of inflammation (which may include pleocytosis, hypoglycorrachia, elevated protein, or other evidence of intrathecal immune activation including IgG index or presence of oligoclonal bands)
    3. systemic infection or inflammatory disease with neurological involvement
    4. neuroimaging suggestive of infection or inflammation (for example, presence of contrast-enhancing lesions on CT or MRI)
    5. clinical presentation suggestive of infection or inflammatory process of the nervous system without better explanation
    6. history of infection or inflammatory process of the nervous system
  2. Be willing to participate in the protocol s procedures, unless clinically contraindicated

  3. Be willing to provide informed consent, either directly or via appointed legally authorized representative

  4. Be willing to consent for collection of clinical data or biological samples or their cryopreservation

  5. Be at least 2 years old

INCLUSION CRITERIA FOR PROCESSING OF BIOLOGICAL SAMPLES ONLY:

At the time of enrollment, participants will:

  1. Have a known or suspected infection or inflammation of the nervous system or post infection sequelae based on clinical or imaging data provided by the referral facility. For the purpose of this study, neuroinfectious disease or neuroinflammation is defined as any of the following:

    1. fever with nervous system signs or symptoms (excluding delirium)
    2. any neurological symptoms accompanied by cerebrospinal fluid (CSF) with evidence of inflammation (which may include pleocytosis, hypoglycorrachia, elevated protein, or other evidence of intrathecal immune activation including IgG index or presence of oligoclonal bands)
    3. systemic infection or inflammatory disease with neurological involvement
    4. neuroimaging suggestive of infection or inflammation (for example, presence of contrast-enhancing lesions on CT or MRI)
    5. clinical presentation suggestive of infection or inflammatory process of the nervous system without better explanation
    6. history of infection or inflammatory process of nervous system
  2. Be willing to provide informed consent, either directly or via appointed legally authorized representative

  3. Be willing to consent for collection of clinical data or biological samples or their cryopreservation

  4. Be at least 2 years old

EXCLUSION CRITERIA:

At the time of enrollment, participants will:

  1. Not have a clinically significant medical condition that, in the best judgment of the investigators, may expose the patient to undue risk of harm or prevent the patient from completing the study (examples include, but are not limited to, ischemic cardiomyopathy, clotting disorder, brittle diabetes)
  2. Not have an acute or unstable medical condition that, in the best judgement of the investigator, would be difficult to handle at the NIH Clinical Center
  3. Not have a clearly-established diagnosis of well-characterized disease entity with validated treatment algorithms for which proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge

EXCLUSION CRITERIA FOR PROCESSING OF BIOLOGICAL SAMPLES ONLY:

At the time of enrollment, participants will not have:

1. A clearly-established diagnosis of well-characterized disease entity with validated treatment algorithms for which proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge

INCLUSION CRITERIA FOR FAMILY MEMBERS:

  1. Have a family member enrolled on 15-N-0125
  2. Be at least 2 years old
  3. Be able to provide informed consent and comply with study procedures

EXCLUSION CRITERIA FOR FAMILY MEMBERS:

1. Not willing to consent for collection of biological samples or their cryopreservation

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
Family Member

A family member of a patient with known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided

Patient

Patient with known or suspected infection or inflammation of the nervous system based on clinical or imaging data provided

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
This is a natural history study of individual cases
기간: 12 months after the last participant is enrolled.

To describe the natural history of inflammatory and infectious diseases of the nervous system and to investigate the relative contribution of underlying pathophysiological processes to morbidity, response to treatment and outcomes.

12 months after the last participant is enrolled.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Avindra Nath, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 5월 6일

기본 완료 (추정된)

2026년 11월 29일

연구 완료 (추정된)

2026년 11월 29일

연구 등록 날짜

최초 제출

2015년 5월 1일

QC 기준을 충족하는 최초 제출

2015년 5월 1일

처음 게시됨 (추정된)

2015년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 10월 9일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 150125
  • 15-N-0125

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .