Analysis of immune-related diseases affecting the central nervous system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the relationship between the immune system and central nervous system (CNS) diseases, particularly focusing on conditions like multiple sclerosis. It will involve two groups: individuals showing symptoms of immune-related CNS damage and healthy volunteers for comparison. Participants will undergo a thorough medical evaluation, including neurological examinations and blood sample collection, to better understand the mechanisms of disability in immune-mediated CNS disorders. The findings may lead to the development of diagnostic tests and new scales for assessing neurological disability and disease severity.

Why it matters

Who can join: the full rules

* 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

For in-person sub-cohort: Able to undergo the required procedures, including LP, MRI and clinical/functional evaluations

PATIENT EXCLUSION CRITERIA (FOR IN-PERSON AND TELEMEDICINE SUB-COHORTS):

Significant medical condition that would make participation in research part of evaluation impossible or risky

For in-person sub-cohort: 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)

Unwilling to consent for collection of biological samples or their cryopreservation

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

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

HEALTHY VOLUNTEER (IN PERSON) EXCLUSION CRITERIA:

Systemic inflammatory disorder, or inflammatory or non-inflammatory neurological diseases

Previous or current history of alcohol and substance abuse

Medical contraindications for MRI (e.g. 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 (e.g. 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 (e.g. 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Bibiana Bielekova, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Amir Moghadam Ahmadi, M.D.
• Email: amir.moghadamahmadi@nih.gov
• Phone: (301) 761-5333

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treadmill-based virtual reality walking training for MS patients

  This study tests whether a treadmill with virtual reality and smart socks can help people with multiple sclerosis walk better and feel safer in daily life.

  Recruiting Shepherd Center, Atlanta GA · Atlanta, Georgia · NCT07927439

• Virtual Reality and Mental Practice to Improve Balance and Walking in Relapsing MS

  This study tests whether virtual reality training or mental practice can improve balance and walking in people with relapsing–remitting multiple sclerosis.

  Recruiting Cairo University · Giza, Giza Governorate · NCT07918339

• REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care

  This study tests how AHSCT compares to high-efficacy MS medicines in adults treated in routine clinical care.

  Recruiting Imperial College London · London and 2 other locations · NCT07899502

• Tolebrutinib in real-world MS care for patients treated by clinicians

  This real-world study sees how tolebrutinib is used for multiple sclerosis patients and what outcomes look like in everyday practice.

  Recruiting Sanofi · Marina, Abu Dhabi Emirate · NCT07898371

• Pilates via live video vs. prerecorded videos for people with multiple sclerosis

  This study tests whether live, coach-led Pilates sessions through video calls are more beneficial than prerecorded Pilates videos for adults with MS.

  Recruiting Yuzuncu Yil University · Van · NCT07893925

• Cooling During Inpatient Rehab for People with MS

  This trial tests whether wearing a cooling vest during intensive training can reduce fatigue and improve walking, strength, balance, and cognition in people with multiple sclerosis during a 3-week inpatient rehab stay.

  Recruiting Klinik Valens · Valens, Canton of St. Gallen · NCT07852156

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.