Clinical trial NCT03244501: Transcranial Static Magnetic Field Stimulation of Frontal Cortex
Official title: Modulation of Frontal Cortical Activity With Transcranial Static Magnetic Field Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: tSMS
Transcranial Static Magnetic Field Stimulation
healthy control
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will receive three stimulations: left frontal, right frontal, and sham tSMS.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Electroencephalogram (EEG) Spectral Power
timeFrame: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Flavio Frohlich, PhD
role: STUDY_DIRECTOR
References: