Transcranial Static Magnetic Field Stimulation of Frontal Cortex

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Active tSMS; Other: Sham tSMS

• Registration Number: NCT03244501
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The purpose of this study is to see if a new brain stimulation technique, static magnetic field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp, can influence normal rhythms of brain activity.

Detailed Description

The investigator's primary objective is to determine the feasibility of modifying frontal brain activity using static magnetic fields. The investigator's will be examining the effects of static magnetic field of the spectral power of EEG data with healthy human participants.

This is a within-subjects design, where each participant will receive sham and active stimulation on the left and right frontal cortex. EEG data will be collected during each stimulation.

Study Timeline

• Study First Submitted: 2017-08-03
• Study Start: 2017-08-08
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-09
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Right-handed, healthy, 18+ years old
• Capacity to understand all relevant risks and potential benefits of the study (informed consent)
• Willing to comply with all study procedures and be available for the duration of the study - Speak and understand English

Exclusion Criteria

• Medical history of Psychological/Emotional Disorders (depression, anxiety, bipolar, etc.)
• (For females) Pregnancy or breast feeding
• Diagnosis of eating disorder (current or within the past 6 months)
• Diagnosis of Obsessive-Compulsive Disorder (lifetime) Attention Deficit Hyperactivity Disorder (currently under treatment)
• Neurological disorders and conditions, including, but not limited to:
• History of epilepsy
• Seizures (except childhood febrile seizures and Electroconvulsive therapy-induced seizures)
• Dementia
• History of stroke
• Parkinson's disease
• Multiple sclerosis
• Cerebral aneurysm
• Brain tumors
• Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment)
• Prior brain surgery Any brain devices/implants, including cochlear implants and aneurysm clips
• Any metal in/on the body, e.g., dental braces, glasses, piercings
• Traumatic brain injury
• Thick hair that would create distance between the magnet and the scalp
• Taking hormonal birth control or hormonal supplements (e.g., testosterone injections) - Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Left Frontal	Active tSMS	An active magnet (active tSMS) will be placed over the left frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the right frontal cortex.
Right Frontal	Active tSMS	An active magnet (active tSMS) will be placed over the right frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left frontal cortex.
Sham Frontal	Sham tSMS	Sham magnets (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left and right frontal cortex.

Primary Outcome Measures

Name	Time	Method
Electroencephalogram (EEG) Spectral Power	4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation	Changes in the spectral power of the EEG before (2 min eyes-closed, 2 min eyes-open), during (eyes-open), and after stimulation (eyes-open)

Secondary Outcome Measures

Name	Time	Method
Heart Rate Variability	4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation	Change in the ratio between the power in low frequency band and the power in high frequency band. As this outcome variable is a ratio between two items that are measured in microvolt\^2, the ratio does not have a unit of measure.

Trial Locations

Locations (1)

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States