The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Magstim Rapid2.
- Кому может быть актуально
- Состояния в реестре: Healthy. Базовые параметры: 18 лет — 39 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
TMSpine: The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity
Обзор
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.
Вмешательства
- Устройство Magstim Rapid2
AIM 1: Investigate the estradiol effect on spinal circuit excitability post afferent (sensory) mediated subthreshold motor priming in young healthy women and men. AIM 2: Characterize the Input output property of spinal circuit excitability following descending drive (motor) mediate priming in young healthy participants AIM 3: Examine the estradiol effect on spinal circuit excitability following descending drive (motor) mediated priming in young healthy females
Первичные конечные точки
- Change in Spinal circuit excitability [Срок оценки: Baseline 1, Post-60mins after peripheral nerve stimulation]
- Change in Motor neuron excitability [Срок оценки: Baseline 2, Post-60mins after priming]
- Change in spinal reflex expression [Срок оценки: Baseline 2, Post-60mins after priming]
- Change in descending drive mediated motor priming [Срок оценки: Baseline 2, Post-60mins after priming]
Критерии участия
FEMALES
Критерии включения
- 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
Критерии исключения
- 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.
MALES
Критерии включения
- Ages 18-39
- Moderately active (less than 7 hours of vigorous physical activity per week)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- University of Texas Southwestern Medical Center — Dallas
Идентификаторы
NCT: NCT06656819 · STU-2020-0738