HealthyTMSpineNCT06656819
The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity
An observational study of Healthy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Magstim Rapid2
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: (1) Healthy females (2) Healthy males (control)
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Subaryani Soedirdjo, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Yu-Chen Chung, PT, Ph.D.
About this study
Official title: TMSpine: The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity
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.
- Conditions
- Healthy
- Being tested
- Magstim Rapid2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim Rapid2Device
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy Females | Not described Receives: Device: Magstim Rapid2 | |
| Healthy Males (control) | Not described Receives: Device: Magstim Rapid2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spinal circuit excitability
Change in Spinal circuit excitability will be assessed by measuring Hoffmann reflex/ M wave ratio of the soleus muscle. Higher scores indicate poorer outcome.
Measured: Baseline 1, Post-60mins after peripheral nerve stimulation
Change in Motor neuron excitability
Changes in motor neuron excitability, as quantified by Delta-F values.
Measured: Baseline 2, Post-60mins after priming
Change in spinal reflex expression
Measured: Baseline 2, Post-60mins after priming
Change in descending drive mediated motor priming
Measured: Baseline 2, Post-60mins after priming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Jul 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Dhaher, University of Texas Southwestern Medical Center
- Investigators
- Yasin Dhaher, Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656819
- Sponsor's protocol ID
- STU-2020-0738
- Acronym
- TMSpine
- Status last verified
- Feb 2026
- First submitted
- 21 Aug 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMSpine: The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity
- ClinicalTrials.gov ID
- NCT06656819
- Acronym / sponsor ID
- TMSpine / STU-2020-0738
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Females | – | Device: Magstim Rapid2 |
| Healthy Males (control) | – | Device: Magstim Rapid2 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- (1) Healthy females (2) Healthy males (control)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magstim Rapid2AIM 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 | Device | Healthy Females, Healthy Males (control) |
Primary outcome
Change in Spinal circuit excitability
Time frame: 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
Time frame: Baseline 2, Post-60mins after priming
Changes in motor neuron excitability, as quantified by Delta-F values.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Subaryani Soedirdjo, Ph.D. contact
Yasin Dhaher, Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chen Chung, PT, Ph.D. (214-648-8838, yu-chen.chung@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spinal circuit excitability (time frame: Baseline 1, Post-60mins after peripheral nerve stimulation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.