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

Completed

• Conditions: Healthy
• Interventions: Device: Single-Pulse Transcranial Magnetic Stimulation

• Registration Number: NCT02833220
• Lead Sponsor: University of Minnesota

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.

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 Timeline

• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Study Start: 2017-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy volunteers between 18-65 years old

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Single-Pulse Transcranial Magnetic Stimulation	* 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Heart Rate Variability from baseline	Change from baseline	Heart rate variability is a non-invasive measurement of the activity of the parasympathetic nervous system

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States