Condition or disease | Intervention/treatment | Phase |
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Role of Sex Hormones Along the Neuromechanical Axis | Device: Transcranial Magnetic Stimulation Device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | N/A |
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 |
Arm | Intervention/treatment |
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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.
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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.
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Ages Eligible for Study: | 18 Years to 39 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pauline Phan, M.S. | 214-648-7954 | Pauline.Phan@UTSouthwestern.edu | |
Contact: Maria P Kabamalan | 214-648-2755 | MariaPia.Kabamalan@UTSouthwestern.edu |
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. |
Principal Investigator: | Yasin Dhaher, Ph.D. | UT Southwestern Medical Center |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 22, 2019 | ||||||||
First Posted Date ICMJE | May 13, 2019 | ||||||||
Last Update Posted Date | December 4, 2020 | ||||||||
Actual Study Start Date ICMJE | April 12, 2019 | ||||||||
Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females | ||||||||
Official Title ICMJE | EMRSHN 2: Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females | ||||||||
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. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Role of Sex Hormones Along the Neuromechanical Axis | ||||||||
Intervention ICMJE | 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.
|
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Study Arms ICMJE | 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.
Intervention: Device: Transcranial Magnetic Stimulation Device
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
70 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 2022 | ||||||||
Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 39 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03947684 | ||||||||
Other Study ID Numbers ICMJE | STU-2018-0192 1R01AR069176-01A1 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Yasin Dhaher, University of Texas Southwestern Medical Center | ||||||||
Study Sponsor ICMJE | University of Texas Southwestern Medical Center | ||||||||
Collaborators ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
Investigators ICMJE |
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PRS Account | University of Texas Southwestern Medical Center | ||||||||
Verification Date | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |