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Trial record 31 of 1359 for:    transcranial magnetic stimulation

The Effects of Single-Pulse Transcranial Magnetic Stimulation on the Autonomic Nervous System in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02833220
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The purpose of this study is to determine the effects of TMS on the ANS. The investigator will determine whether single-pulse TMS of the primary motor cortex in the dominant hemisphere in healthy, young adults will affect 1) heart rate and heart rate variability, 2) blood pressure and 3) baroreflex function. This study is foundational in that it will begin to characterize how single-pulse TMS affects the ANS in healthy adults.

Condition or disease Intervention/treatment
Healthy Device: Single-Pulse Transcranial Magnetic Stimulation

Detailed Description:

The overall purpose of this study is to investigate the effects of TMS on the ANS. Specifically; the investigator aim to determine if single-pulse TMS of the primary motor cortex in the dominant hemisphere in healthy, young adults will significantly affect 1) heart rate and heart rate variability, 2) blood pressure and 3) baroreflex function.

The first purpose of this study is to measure alterations in sympathetic and parasympathetic activation in response to TMS. To do this, we will measure HRV immediately after single-pulse TMS. The second purpose is to investigate the changes in blood pressure in response to TMS and to determine whether the baroreflex, a critical modulator of blood pressure, is inhibited by TMS.

Aim 1: To determine if single-pulse TMS of the primary motor cortex will significantly alter heart rate variability. We hypothesize that single-pulse TMS of the primary motor cortex will elicit an acute decrease in heart rate and result in improved heart rate variability indicated by a significantly decreased LF power and increased HF power.

Aim 2: To determine if single-pulse TMS of the primary motor cortex will significantly alter blood pressure and baroreflex sensitivity (BRS). We hypothesize that single-pulse TMS of the primary motor cortex will elicit an acute decrease in blood pressure by inhibiting the baroreflex.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Single-Pulse Transcranial Magnetic Stimulation on the Autonomic Nervous System in Healthy Adults
Study Start Date : January 2017
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Group/Cohort Intervention/treatment
Healthy volunteers
  • Healthy adults between the ages of 18-65 are eligible.
  • Participants will receive non-invasive brain stimulation by way of single-pulse transcranial magnetic stimulation to the motor cortex
Device: Single-Pulse Transcranial Magnetic Stimulation
Single-pulse Transcranial Magnetic Stimulation activates neurons within the cortex of the brain by way of electromagnetic induction. This causes a small, focused electric field to become present in the brain, which activates the neurons.




Primary Outcome Measures :
  1. Change in Blood Pressure during the intervention as compared to baseline [ Time Frame: Change from baseline ]
    It is possible that blood pressure is changing when the single-pulse transcranial magnetic stimulation is being delivered.


Secondary Outcome Measures :
  1. Change in Heart Rate Variability from baseline [ Time Frame: Change from baseline ]
    Heart rate variability is a non-invasive measurement of the activity of the parasympathetic nervous system



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy adults
Criteria

Inclusion Criteria:

  • healthy volunteers between 18-65 years old

Exclusion Criteria:

  • pregnant or breastfeeding women
  • previous episodes of seizures or fainting
  • any implanted metal in their head
  • history of migraines
  • history of psychiatric disorder (e.g. depression, anxiety, ADHD, bi-polar disorder)
  • currently taking medications that may alter autonomic function (e.g. blood pressure medication, depression medication)

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): NCT02833220


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Manda L Keller-Ross, PhD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02833220     History of Changes
Other Study ID Numbers: TMS and BP
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
blood pressure
heart rate variability
single-pulse transcranial magnetic stimulation
non-invasive brain stimulation