Transcranial Static Magnetic Field Stimulation of Frontal Cortex

University of North Carolina (UNC)

Status: Completed

Conditions: Healthy

Treatments: Other: Sham tSMS; Other: Active tSMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03244501

17-1022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Left Frontal

Experimental group

Description:

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.

Treatment:

Other: Active tSMS

Right Frontal

Experimental group

Description:

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.

Treatment:

Other: Active tSMS

Sham Frontal

Sham Comparator group

Description:

Sham magnets (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left and right frontal cortex.

Treatment:

Other: Sham tSMS