Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Malattie infiammatorie e infettive del sistema nervoso

Studio di storia naturale delle malattie infiammatorie e infettive del sistema nervoso

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

1000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Maryland
      • Bethesda, Maryland, Stati Uniti, 20892
        • Reclutamento
        • National Institutes of Health Clinical Center
        • Contatto:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • Numero di telefono: TTY dial 711 800-411-1222
          • Email: ccopr@nih.gov

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 2 anni a 110 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
This is a natural history study of individual cases
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 maggio 2015

Completamento primario (Stimato)

29 novembre 2026

Completamento dello studio (Stimato)

29 novembre 2026

Date di iscrizione allo studio

Primo inviato

1 maggio 2015

Primo inviato che soddisfa i criteri di controllo qualità

1 maggio 2015

Primo Inserito (Stimato)

6 maggio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

9 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 150125
  • 15-N-0125

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .