Transcranial Static Magnetic Field Stimulation of Frontal Cortex

NCT03244501 | Completed

• 1 other identifier: 17-1022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

tSMS; Transcranial Static Magnetic Field Stimulation; healthy control

Outcome Measures

Primary Outcomes (1)

• Electroencephalogram (EEG) Spectral Power

  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)

  4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation

Secondary Outcomes (1)

• Heart Rate Variability

  4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation

Study Arms (3)

Left Frontal

EXPERIMENTAL

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.

Other: Active tSMS

Right Frontal

EXPERIMENTAL

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.

Other: Active tSMS

Sham Frontal

SHAM COMPARATOR

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

Other: Sham tSMS

Interventions

Active tSMS OTHER

A cylindrical neodymium magnet is placed above the scalp.

Left Frontal; Right Frontal

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.

Sham Frontal

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Study Officials

• Flavio Frohlich, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for providing the study coordinator with the active and sham magnet sequence. Each magnet has a number; the study coordinator is not aware which number corresponds to active or sham magnets.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive three stimulations: left frontal, right frontal, and sham tSMS.

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 9, 2017
• Study Start: August 8, 2017
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)