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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System

Study Purpose

Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS). This study will compare tests performed on both healthy volunteers and individuals who have signs or symptoms of immune-related damage to their CNS. This study will include two groups of subjects at least 12 years old. Subjects will either have symptoms of immune-related CNS damage, or will be healthy volunteers selected for comparison purposes. Study participants will visit the NIH Clinical Center on an outpatient basis for an initial evaluation visit. During the visit, patients will provide a comprehensive medical history and undergo a neurological examination, and will provide blood samples for research purposes. The healthy volunteers will be asked to schedule a return visit for a magnetic resonance imaging (MRI) procedure, and may be asked to undergo other tests requested by the study researchers on an as-needed basis. The group of patients with symptoms of immune-related CNS damage will be asked to undergo a series of tests, including the following:

  • - MRI procedures, with a minimum of three brain MRIs and one spinal cord MRI taken approximately 4 weeks apart.
  • - A diagnostic lumbar puncture, performed on an outpatient basis.
  • - Tests of brain and vision activity.
  • - Additional blood and tissue samples.
Patients with symptoms of immune-related CNS damage may be offered the opportunity to participate in additional followup tests with NIH researchers.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 1 Month - 99 Years
Gender All
More Inclusion & Exclusion Criteria

  • - PATIENT INCLUSION CRITERIA (for in-person and telemedicine sub-cohorts): Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or.
Neuroimaging evidence of inflammatory and/or demyelinating/ dysmyelinating CNS disease. At least 12 years old at the time of enrollment. Willing to share medical records (including past MRI results) with the study team. Adults: Able to give informed consent on their own or via a Legally Authorized Representative (LAR) or Durable Power of attorney (DPA), or Minors: parent or legal guardian able to give consent, with child willing to give assent, if reasonable based on their age and assent capacity, able to give assent with consent given by their parent or legal guardian. For in-person sub-cohort: Able to undergo the required procedures, including LP, MRI and clinical/functional evalautions. HEALTHY VOLUNTEER (in person)

INCLUSION CRITERIA:

At least 18 years old at the time of enrollment. Vital signs are found within normal range at the time of the screening visit. Able to give informed consent. Able and willing to undergo related research procedures, such as blood draw, LP. PATIENT INCLUSION CRITERIA for processing of collected biological samples: Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or. Neuroimaging evidence of inflammatory and/or demyelinating/ dysmyelinating CNS disease. Ability to obtain either direct or surrogate informed consent for sample processing and storage. Aged 0+ years. PATIENT EXCLUSION CRITERIA (for in-person and telemedicine subcohorts): Significant medical condition that would make participation in diagnostic and research part of evaluation impossible or risky. For in-person sub-cohort: Medical contraindications for MRI (ie- any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed) Unable to provide informed consent. Unwilling to consent for collection of biological samples or their cryopreservation. HEALTHY VOLUNTEER (in person)

EXCLUSION CRITERIA:

Systemic inflammatory disorder or inflammatory or non-inflammatory nurological diseases. Previous or current history of alcohol and substance abuse. Medical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed) Medical contraindication for LP. Psychological contraindications for MRI (i.e. claustrophobia). This will be assessed at the time the medical history is collected. Pregnancy or current breastfeeding. Any contraindications to having study procedures done History of auditory disorder (i.e. hearing impairment, known impaired acoustic reflex, tinnitus) HEALTHY VOLUNTEER SUB STUDY TO OBTAIN NORMATIVE DATA FOR THE SMARTPHONE APPS: Because this sub study collects no personal identifiable information (PII), there are no inclusion/exclusion criteria. Participating subjects are self-declared as not having any neurological deficit, which would be the same population that would provide normative data if the apps were freely available via App store.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00794352
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bibiana Bielekova, M.D.
Principal Investigator Affiliation National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Central Nervous System Disease, Multiple Sclerosis
Study Website: View Trial Website
Additional Details

The goal of this study is to define the pathophysiological mechanisms underlying the development of disability in immune-mediated disorders of the central nervous system (CNS) and to distinguish these from beneficial responses of the human immune system to CNS injury. The protocol serves as a screening tool for Neuroimmunological Diseases Section (NDS) of the National Institute of Allergy and Infectious Diseases (NIAID) clinical trials and enables development of clinically-useful tools such as diagnostic tests and new, sensitive scales of neurological disability, disease severity and CNS tissue destruction. This protocol also serves as a repository to enable prospective institutional review board (IRB) review of research using human samples and data collected under other NDS protocols.

Arms & Interventions

Arms

: Healthy Volunteer

Healthy patients with NO inflammatory and/or demyelinating/dysmyelinating diseases of the CN

: Patient Cohort

Patients who present with CNS white matter injury (including inflammatory and/or demyelinating/dysmyelinating diseases of the CNS)

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

[email protected]

(301) 496-7183

Nearest Location

Site Contact

[email protected]

(301) 496-7183


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

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Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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