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

NCT02833220 | Completed FDA Device

• 1 other identifier: TMS and BP
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

blood pressure; heart rate variability; single-pulse transcranial magnetic stimulation; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Heart Rate Variability from baseline

  Change from baseline

Study Arms (1)

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

Interventions

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.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

healthy adults

You may qualify if:

• healthy volunteers between 18-65 years old

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Manda L Keller-Ross, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 14, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)