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Completed

NCT Number: NCT02833220

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Single-Pulse Transcranial Magnetic Stimulation

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 14, 2016
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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