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Transcranial Static Magnetic Field Stimulation of Frontal Cortex

NCT ID: NCT03244501

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2017-09-15

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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tSMS Transcranial Static Magnetic Field Stimulation healthy control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants will receive three stimulations: left frontal, right frontal, and sham tSMS.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Left Frontal

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.

Group Type EXPERIMENTAL

Active tSMS

Intervention Type OTHER

A cylindrical neodymium magnet is placed above the scalp.

Right Frontal

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.

Group Type EXPERIMENTAL

Active tSMS

Intervention Type OTHER

A cylindrical neodymium magnet is placed above the scalp.

Sham Frontal

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

Group Type SHAM_COMPARATOR

Sham tSMS

Intervention Type OTHER

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

Interventions

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Active tSMS

A cylindrical neodymium magnet is placed above the scalp.

Intervention Type OTHER

Sham tSMS

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Flavio Frohlich, PhD

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Locations

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UNC Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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17-1022

Identifier Type: -

Identifier Source: org_study_id