TMSpine: The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Spinal circuit excitability
研究概览
简要总结
The goal of this project is to test our central hypothesis that the spinal cord neuroplasticity in females will be modulated by the level of estradiol concentration. under aim 1 we will determine the influence of estradiol fluctuations on spinal circuit excitability post afferent (sensory) mediated subthreshold motor priming in young healthy females and males. We will use an established repetitive peripheral nerve electrical stimulation with a stimulation intensity below the motor threshold to prime the spinal motor circuits. under aim 2 we seek to characterize the input output property of spinal circuit excitability after descending drive (motor) mediated priming in young healthy male participants. in aim 3 we will examine the influence of estradiol fluctuations on descending drive mediated motor priming in young healthy females.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Ages 18-39 years
- •Eumenorrheic (regular monthly cycles of 24-35 days)
- •Moderately active (less than 7 hours of vigorous physical activity per week)
- •History of pregnancy is allowed if patient is in post-lactation phase
排除标准
- •History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot
- •History of neurological injury of the peripheral or central nervous system
- •Current smoker
- •History of disordered eating
- •History of stress fracture in the lower limb
- •History of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease)
- •Pacemaker, metal implants in the head and spine region
- •Pregnancy
- •On a hormonal contraceptive regimen (oral, transdermal or vaginal)
- •History of menstrual dysfunction (primary or secondary amenorrhea, oligomenorrhea, anovulatory cycles, polycystic ovarian disease)
- •Started or stopped taking oral contraceptives within the previous 6 months
- •Exercise vigorously more than 7 hours per week or currently participating in competitive level sports.
- •Inclusion Criteria:
- •Ages 18-39
- •Moderately active (less than 7 hours of vigorous physical activity per week)
- •Exclusion Criteria:
- •History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot
- •History of neurological injury of the peripheral or central nervous system
- •Current smoker
- •History of disordered eating
- •History of stress fracture in the lower limb
- •History of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease)
- •Pacemaker, metal implants in the head and spine region
结局指标
主要结局
Change in Spinal circuit excitability
时间窗: Baseline 1, Post-60mins after peripheral nerve stimulation
Change in Spinal circuit excitability will be assessed by measuring Hoffmann reflex/ M wave ratio of the soleus muscle. Higher scores indicate poorer outcome.
Change in Motor neuron excitability
时间窗: Baseline 2, Post-60mins after priming
Changes in motor neuron excitability, as quantified by Delta-F values.
Change in spinal reflex expression
时间窗: Baseline 2, Post-60mins after priming
Change in descending drive mediated motor priming
时间窗: Baseline 2, Post-60mins after priming
次要结局
未报告次要终点
研究者
Yasin Dhaher
Professor
University of Texas Southwestern Medical Center