Development of the measurement of the blood brain barrier breakdown and myelin damage by brain MRI in healthy controls abd patients with multiple sclerosis and neuromyelitis optica spectrum disorder.

JRCT ID: jRCT1031210006

Registered date:02/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: multiple sclerosis, neuromyelitis optica sspectrum disorders,healthy controls
• Date of first enrollment: 02/04/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Blood Specimen Collection, Spinal Puncture, contrast enhanced MRI

Outcome(s)

• Primary Outcome: Correlation between Ki (calculated by MRI) and Quotient albumin (showing the blood barrier breakdown and calculated by lumber tap) in the three groups (MS, NMOSD, HCs).

Secondary Outcome

1. Correlation between Ki and white blood cell in the cerebrospinal fluid (CSF), serum and CSF cytokines, or myelin mapping in the three groups (MS, NMOSD, HCs).
2. Comparing these data between disease group (MS and NMOSD) and HCs.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1) Patients who fulfill the diagnostic criteria of multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) will be included. Patients within 14 days from the attack and before the treatment will be included.
2) Healthy controls (HCs) aged from 20 to 65 years old will be included.
3) Patients and HCs who provide the informed consent will be included.
4) Patients and HCs aged frin 20 to 65 years old will be included. Men and women will be included.
5)

Exclude criteria

Exclusion criteria is shown below;
1) Patients or HCs who cannot take MRI due to the pacemaker, pregnancy, claustrophobia, and active asthma.
2) Patients of HCs who showed allergy for the contrast medium.
3) Patients or HCs with renal impairment: eGFR less than 30mL/min/1.73m2 for patients, eGFR less than 60mL/min/1.73m2 for HCs.
4) Patients or HCs who are considered as inappropriate by investigators.
5) HCs who are considered to have increased intracranial pressure and the possibility to cause the brain herniation by lumber tap.
6) HCs who have neurological disease, hematologic disease, renal desease, endocrine disease, lung disease, gastrointestinal disease, liver disease, mental disease, or the past history of the mental disorder.
7) HCs who have the past history of severe trauma of the brain or spine, or the past history of the gastrointestinal bleeding, urinary tract bleeding, or major surgery within 3 months.
8) HCs who are considered as inappropriate by investigators from the point of view of the tests including blood test or blood pressure.
9) HCs who took part in the clinical trial for the new drug within 4 months or took part in other clinical trials and received drugs within 3 months.
10) HCs who take the regular medicine including over-the-counter drugs.
11) HCs who are considered as inappropriate by investigators from the medical judgement.

Related Information

• Primary Sponsor: Masuda Hiroki
• Source(s) of Monetary Support: Takahashi Industrial and Economic Research Foundation