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Recruiting NCT06656819

The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity

— Observational Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magstim Rapid2.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

TMSpine: The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity

Overview

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.

Interventions

  • Device 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

Primary outcome measures

  • Change in Spinal circuit excitability [Time frame: Baseline 1, Post-60mins after peripheral nerve stimulation]
  • Change in Motor neuron excitability [Time frame: Baseline 2, Post-60mins after priming]
  • Change in spinal reflex expression [Time frame: Baseline 2, Post-60mins after priming]
  • Change in descending drive mediated motor priming [Time frame: Baseline 2, Post-60mins after priming]

Eligibility criteria

FEMALES

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

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
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Texas Southwestern Medical Center — Dallas

Identifiers

NCT: NCT06656819 · STU-2020-0738

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗