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Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females (EMRSHN)

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ClinicalTrials.gov Identifier: NCT03947684
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Yasin Dhaher, University of Texas Southwestern Medical Center

Brief Summary:
The goal of this project is to test our central hypothesis that changes in sex hormone concentration result in changes to the basic elements of motor control - at multiple levels, from the musculotendinous unit to motor control circuitry. Under Aim 1 the investigator will determine the influence of sex hormone fluctuations on the muscle stretch reflex during active and passive states, and the time lag between hormone concentration changes and the reflex response. The investigator will use a technically simple assessment that could be implemented in the field. Under Aim 2 the investigator will determine the influence of sex hormone fluctuations on spinal motor neuron excitability using H-reflex as a probe and the simultaneous change in the muscle mechanics using muscle twitch response. Aims 1 & 2 will include a focus on the differential role of oral contraceptives. In Aim 3 the investigator will use paired-pulse transcranial magnetic stimulation during active contraction to determine the influence of sex hormone fluctuation.

Condition or disease Intervention/treatment Phase
Role of Sex Hormones Along the Neuromechanical Axis Device: Transcranial Magnetic Stimulation Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: EMRSHN 2: Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females
Actual Study Start Date : April 12, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: TMS
Paired-pulse transcranial magnetic stimulation during active contraction to determine the influence of sex hormone fluctuations on cortical excitability in naturally cycling women.
Device: Transcranial Magnetic Stimulation Device
The TMS device electrically stimulates the intended parts of the brain. In this study, the investigator plan to target the part of the brain cortex that is responsible for the voluntary motion of the leg muscles, whose functions are under investigation.




Primary Outcome Measures :
  1. Sex hormone fluctuations on muscle stretch reflex at relaxed and active states. [ Time Frame: 2 months ]
    Blood draw for Estradiol, Progesterone, and Testosterone.

  2. Tendon tap reflex testing. [ Time Frame: 2 months ]
    The muscle reflex will be evoked by tapping the patellar tendon with a hammer instrumented with a load cell. The load cell instrumented hammer will allow us to quantify the reflex gain by normalizing the reflex EMG by the tap force.

  3. Anterior knee laxity measurement. [ Time Frame: 2 months ]
    To assess the joint's connective tissue response at varying points in the cycle, anterior knee laxity (AKL) will be measured with the knee arthrometer.


Secondary Outcome Measures :
  1. H-reflex testing. [ Time Frame: 2 months ]
    For the monosynaptic H-reflex testing, a stimulating bar bipolar electrode will be placed over the tibial nerve in the popliteal fossa with the anode positioned distally. The H-reflex and M-Wave will be recorded from the soleus muscle using surface EMG electrodes placed over the muscle belly at the myotendinous junction.

  2. Polysynaptic reflex testing. [ Time Frame: 2 months ]
    For polysynaptic reflex testing, stimulation will be applied behind the medial malleolus of the ankle to the distal tibial nerve using a Grass Instruments S48 Stimulator, a Grass SIU5 Stimulus Isolation Unit and a Grass Constant Current Unit. EMG recordings will be taken from the tibialis anterior muscle using self-adhesive surface electrodes. Data collection will include 20 series of 8 train pulses.


Other Outcome Measures:
  1. Sex hormone fluctuations on cortical excitability using transcranial magnetic stimulation (TMS). [ Time Frame: 1 month ]
    MRI images will be acquired prior to the first TMS laboratory visit. The TMS coil will be positioned over the intersection of the central sulcus with the mid-sagittal plane using the subject's own anatomical MRI using an optical navigation system. Surface EMG will be recorded from muscles in the right leg. The paired-pulse paradigm isolates any modulatory influence of hormone concentration at cortex. With the subject seated with hip, knee, and ankle flexed at 90 degrees, TMS will be delivered to the leg area of the left motor cortex through using one of our TMS systems.

  2. Ovulation testing. [ Time Frame: 1 month ]
    Urine ovulation kit.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females: ages 18-39 years, who are eumenorrheic (regular monthly cycles of 24-35 days) or on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal), no history of pregnancy, moderately active (less than 7 hours of vigorous physical activity per week)
  • Males: Ages 18-39

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).
  • For female participants only: Point of care screening for anemia will be completed, and individuals with hemoglobin levels <11.6 g/dl will be excluded from participating in the study.
  • Specific exclusion criteria for TMS (male and female): pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, and pregnancy.
  • Additional exclusion criteria for female participants: History of menstrual dysfunction (primary or secondary amenorrhea, oligomenorrhea, anovulatory cycles, polycystic ovarian disease), current or past pregnancy, 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. The reason for excluding highly active or competitive athletes is due to the high rate of undiagnosed menstrual dysfunction in females of this population.
  • This study will not include: adults unable to consent, Individuals who are not yet adults (infants, children, teenagers), pregnant women or prisoners.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947684


Contacts
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Contact: Pauline Phan, M.S. 214-648-7954 Pauline.Phan@UTSouthwestern.edu
Contact: Maria P Kabamalan 214-648-2755 MariaPia.Kabamalan@UTSouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Pauline Phan, M.S.    214-648-7954    Pauline.Phan@UTSouthwestern.edu   
Contact: Maria P Kabamalan    214-648-2755    MariaPia.Kabamalan@UTSouthwestern.edu   
Principal Investigator: Yasin Dhaher, Ph.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Yasin Dhaher, Ph.D. UT Southwestern Medical Center

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Responsible Party: Yasin Dhaher, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03947684     History of Changes
Other Study ID Numbers: STU-2018-0192
1R01AR069176-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Yasin Dhaher, University of Texas Southwestern Medical Center:
Sex Hormones

Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs