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Transcranial Magnetic Stimulation Device for Role of Sex Hormones in Neuromuscular Function (EMRSHN Trial)

N/A
Recruiting
Led By Yasin Dhaher, Ph.D.
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males: Ages 18-39
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

EMRSHN Trial Summary

This trial seeks to understand how changes in sex hormones can affect muscle reflexes and motor control at different levels.

Who is the study for?
This trial is for females aged 18-39 with regular monthly cycles or on stable hormonal contraceptives, and males of the same age. Participants should be moderately active but not excessively (under 7 hours of vigorous activity per week), and females must have no history of pregnancy.Check my eligibility
What is being tested?
The study investigates how sex hormone levels affect motor control from muscles to brain circuitry. It involves testing muscle reflexes, spinal neuron excitability using H-reflex, muscle mechanics, and brain stimulation via a device during muscle contraction.See study design
What are the potential side effects?
While specific side effects are not listed, transcranial magnetic stimulation may cause discomfort at the stimulation site, mild headache or lightheadedness temporarily after the procedure.

EMRSHN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged between 18 and 39.

EMRSHN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anterior knee laxity measurement.
Sex hormone fluctuations on muscle stretch reflex at relaxed and active states.
Tendon tap reflex testing.
Secondary outcome measures
H-reflex testing.
Polysynaptic reflex testing.
Other outcome measures
Ovulation testing.
Sex hormone fluctuations on cortical excitability using transcranial magnetic stimulation (TMS).

EMRSHN Trial Design

1Treatment groups
Experimental Treatment
Group I: TMSExperimental Treatment1 Intervention
Paired-pulse transcranial magnetic stimulation during active contraction to determine the influence of sex hormone fluctuations on cortical excitability in naturally cycling women.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,705 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,775 Total Patients Enrolled
Yasin Dhaher, Ph.D.Principal Investigator - UT Southwestern Medical Center
University of Texas Southwestern Medical Center
1 Previous Clinical Trials
15 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size for this research endeavor?

"Affirmative. The trial is actively recruiting according to information available on clinicaltrials.gov; the original post was published in April 12th 2019 and has been recently edited as of June 30th 2022. 70 participants are needed from a single site for this research study."

Answered by AI

Could I be considered for admission into this research trial?

"This medical trial seeks 70 individuals aged 18-39 whose sex hormones interact with the neuromechanical axis. Female participants must fall within this age range and not have experienced a pregnancy before, in addition to having regular menstrual cycles of 24-35 days or be on an established hormonal contraceptive for 6 months (oral, transdermal or vaginal) as well as exercising moderately (less than 7 hours per week)."

Answered by AI

Is the age criterion of 50 years or older a requirement for enrolment in this research?

"This medical trial seeks out candidates between the ages of 18 and 39."

Answered by AI

Are participants being accepted for this clinical experiment at present?

"Affirmative. Records on clinicaltrials.gov confirm that this health study, having been initially uploaded on April 12th 2019, is actively seeking participants. Seventy patients are needed to be recruited from 1 particular medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females
Yasin Dhaher 2019. "Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03947684.
~0 spots leftby May 2024
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