Effect of Thyroid hormones on imaging findings of patients with multiple sclerosis

Phase 1

• Conditions: Multiple Sclerosis.; Multiple sclerosis (of): NOS brain stem cord disseminated generalized

• Registration Number: IRCT201210051859N6
• Lead Sponsor: Tehran University Of Medical Sciences,vice chancellor for research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1)Definite diagnosis of relapsing-remitting Multiple Sclerosis according to McDonald criteria revised in 2010 (Polman, Reingold et al. 2011).
2)Admission during the relapse phase (in the first 2 weeks from the onset of symptoms)
Relapse definition: appearance of a new sign or exacerbation of a present sign which lasts for at least 24 hours without infection or any other possible reason. (Signs consist of Hemiparesis, paraparesis, hemiataxia, myelopathy, any sensation disorder.)
3)5 days IV Methylprednisolone therapy for relapse.
4)Expanded Disability Scale Status (before relapse) equal or less than 5.5.
5)Age between 23 and 55 years old.
6)Minimum disease duration of 5 years.

Exclusion criteria:
1)Thyroid function tests impairment (Thyroid Stimulating Hormone level less than 1 µIU/mL).
2)Administration of other drugs containing thyroid hormones during /prior to the study.
3)Prior administration of cytotoxic/immunosuppressive medications (e.g. mitoxantrone, azathioprine, cellcept)
4)Existence of any medical condition which is a contraindication for administering thyroid hormones: history of arrhythmia, myocardial infarction or congestive heart disease, heart failure, resting pulse rate more than 90/min, history of autoimmune thyroid disease, thyroid adenoma, hyperthyroidism, adrenal cortical insufficiency, diabetes, pregnancy, breast feeding, and women in reproductive age who do not use a safe birth control method.
5)History of central nervous system disorders other than multiple sclerosis, psychiatric, metabolic, rheumatologic and autoimmune disorders, and drug or alcohol abuse during the last month before study.
6)History of brain damage, cancer, chronic liver, kidney, heart or endocrine disease and vitamin D metabolic disorders.
7)Medications interfering absorption or metabolism of thyroid hormones such as oral contraceptives and Cholestyramine.
8)Medications which absorption or metabolism is affected by thyroid hormones, such as Tricyclic antidepressants and anticoagulants.
9)Abnormal rhythm or repolarization phase disorders in Electrocardiogram.
10)Disability to take Magnetic resonance imaging.
11)Disability to read or understand the informed consent.
12)Participation in any other clinical trial during the past 3 months.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Voxel-wise Magnetization Transfer Ratio changes in Gadolinium enhancing lesions. Timepoint: before intervention,3 months after initiation. Method of measurement: Magnetic Resonance Imaging with contrast.

Secondary Outcome Measures

Name	Time	Method
Voxel-wise Magnetization Transfer Ratio changes in normal appearing white matter. Timepoint: before intervention,3 months after initiation. Method of measurement: Magnetic Resonance Imaging.;Expanded Disability Status Scale (EDSS). Timepoint: before intervention,3 months after initiation. Method of measurement: physical examination.;Symbol digit modalities test (SDMT). Timepoint: before intervention,3 months after initiation. Method of measurement: physical examination.;Voxel-wise Magnetization Transfer Ratio changes in Gadolinium non-enhancing lesions. Timepoint: before intervention,3 months after initiation. Method of measurement: Magnetic Resonance Imaging.