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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

healthy adults

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate Variability from baseline	Heart rate variability is a non-invasive measurement of the activity of the parasympathetic nervous system	Change from baseline

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Manda L Keller-Ross, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: blood pressure; heart rate variability; non-invasive brain stimulation; single-pulse transcranial magnetic stimulation
• Other Study ID Numbers: TMS and BP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No