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临床试验/NCT04098991
NCT04098991已完成不适用

Improving White Matter Integrity With Thyroid Hormone

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年11月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Multi-Component Relaxometry

研究概览

简要总结

Animal studies have shown that thyroid hormone can improve white matter integrity after damage to myelin, which insulates and protects nerves. It is currently unknown whether this type of repair can occur in humans. The purpose of the proposed study is to examine the impact of thyroid hormone on white matter integrity in humans using two complementary, state-of-the-art neuroimaging techniques: high angular diffusion imaging and multicomponent relaxometry.

详细描述

The ability to promote and support remyelination has wide-ranging implications for a number of neuropsychiatric conditions from multiple sclerosis to major depression. Pre-clinical evidence has demonstrated that thyroid hormone treatment, in the form of triiodothyronine (T3) or tetraiodothyronine (T4), can promote and support remyelination by increasing myelin basic protein mRNA and protein, oligodendrocyte proliferation and maturation, and fractional anisotropy (a diffusion imaging measure of white matter integrity). Pilot data from the investigator's studies suggest that baseline thyroid status is correlated with the integrity of white matter tracts associated with major depression. To date, the impact of thyroid hormone administration on white matter tracts has not been studied in vivo in adult humans. The purpose of the proposed pilot study is to examine changes in white matter tract integrity using high angular diffusion imaging and multi-component relaxometry in a population of subjects clinically indicated to receive thyroid hormone for hypothyroidism. The investigators will scan patients with hypothyroidism at the initiation of treatment and at three and six months after starting thyroid hormone treatment. The investigators will also administer scales assessing mood and cognition which have been shown to correlate with white matter integrity. The investigators hypothesize that thyroid hormone treatment will be associated with an increase in fractional anisotropy, a decrease in radial diffusivity, and an increase in the myelin water fraction (markers of improved myelination) that will correlate with improvements in cognition and mood ratings. If successful, this will be the first demonstration of improved white matter integrity with thyroid hormone replacement and pave the way for therapies designed to restore structural brain connectivity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 21-60 years of age
  • A diagnosis of primary hypothyroidism from autoimmune thyroiditis (Hashimoto)
  • Able to give informed consent.

排除标准

  • Major depressive disorder with or without active suicidal ideation
  • Mild or major neurocognitive disorder;
  • Presence of contraindications to magnetic resonance imaging (presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
  • Inability to tolerate small, enclosed spaces without anxiety (e.g., claustrophobia)
  • Unwilling/unable to sign informed consent document
  • Positive urine drug screen results;
  • Pregnancy (positive pregnancy test), trying to become pregnant, or lactation

研究组 & 干预措施

Participants with primary hypothyroidism

All participants will receive the same treatment (levothyroxine, a synthetic T4 hormone replacement) at a dose that will be titrated using serum thyrotropin (TSH) levels as a goal, according to the American Thyroid Association Task Force recommendations

干预措施: Levothyroxine (Drug)

结局指标

主要结局

Multi-Component Relaxometry

时间窗: 6 months

Change in baseline white matter track integrity at 3 months and 6 months

High Angular Diffusion Tensor Imaging

时间窗: 6 months

Change in baseline white matter track integrity at 3 months and 6 months

次要结局

  • Patient Health Questionaire(Collected at Baseline, 3 month follow-up, 6 month follow-up)
  • NIH Toolbox : Dimensional Change Card Sort Test(Collected at Baseline, 3 month follow-up, 6 month follow-up)
  • NIH Toolbox : Pattern Comparison Processing Speed Test(Collected at Baseline, 3 month follow-up, 6 month follow-up)
  • NIH Toolbox : Flanker Inhibitory Control and Attention Test(Collected at Baseline, 3 month follow-up, 6 month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olusola Alade Ajilore

Associate Professor Associate Director, Residency Training and Education Co-Director, Adult/Neuroscience Research Track

University of Illinois at Chicago

研究点 (1)

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