Healthy Clinical Trial
Official title:
Modulation of Frontal Cortical Activity With Transcranial Static Magnetic Field Stimulation
Verified date | October 2017 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | September 15, 2017 |
Est. primary completion date | September 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UNC Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Heart Rate Variability | 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. | 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation |
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