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Completed

NCT Number: NCT03244501

Transcranial Static Magnetic Field Stimulation of Frontal Cortex

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active tSMS

Other

A cylindrical neodymium magnet is placed above the scalp.

Sham tSMS

Other

A cylindrical piece of nonferrous metal (brass). This is not attracted to magnets, and is identical in weight and appearance to active magnets.

Primary outcomes

  1. Electroencephalogram (EEG) Spectral Power

    Time frame: 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 outcomes

  1. Heart Rate Variability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Modulation of Frontal Cortical Activity With Transcranial Static Magnetic Field Stimulation

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2017
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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