The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity

NCT ID: NCT06656819

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Females

Magstim Rapid2

Intervention Type DEVICE

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

Healthy Males (control)

Magstim Rapid2

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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
* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasin Dhaher

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yasin Dhaher, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yu-Chen Chung, PT, Ph.D.

Role: CONTACT

Phone: 214-648-8838

Email: [email protected]

Subaryani Soedirdjo, Ph.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yu-Chen Chung, PT, Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU-2020-0738

Identifier Type: -

Identifier Source: org_study_id