Effect of tACS Stimulation on Alpha Oscillations

Healthy Clinical Trial

— AIMS1  

Official title:

Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178344
• Other study ID #: 16-1911a
• Secondary ID: R01MH111889-01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: November 4, 2017

Study information

• Verified date: February 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transcranial Alternating Current Stimulation (tACS) is one method that has been demonstrated to enhance alpha oscillations in healthy participants by applying weak electrical currents to the scalp to modulate rhythmic brain activity patterns. This study will involve tACS-induced frontal alpha oscillations, EEG recordings, and other physiological and biological measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 4, 2017
• Est. primary completion date: November 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ages 18-65

• Capacity to understand all relevant risks and potential benefits of the study (informed consent)

• Negative pregnancy test for female participants

Exclusion Criteria:

• History of major neurological or psychiatric illness, including epilepsy

• Medication use associated with neurological or psychiatric illnesses

• Currently undergoing counseling or psychotherapy treatment for depression, anxiety, eating disorders, PTSD or other behavioral conditions

• First degree relative (parent, sibling, child) with major neurological or psychiatric illness

• Prior brain surgery

• Major head injury

• Any brain devices/implants (including cochlear implants and aneurysm clips)

• Braids or other hair styling that prevents direct access to the scalp (if removal not possible)

• Skin allergies or very sensitive skin

• Pregnant or nursing females

• Failure to pass a urinary drug test at the first session

• Use of hormonal birth control or supplements in the past two weeks

• Non English speakers

• Cardiovascular disease

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• XCSITE100 Stimulator tACS
Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
• XCSITE100 Stimulator Sham
The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary Alpha Amylase	Change after stimulation	Before and after 40-minute stimulation at each session.
Primary	Salivary Cortisol	Change before and after stimulation	Before and after 40 minutes of 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.	Before and after 40-minute stimulation at each session.
Secondary	Percent Change in Respiration	Respiration rate, measured via a belt placed around the participant's abdomen as breaths per second.	Before and after 40-minute stimulation at each session.
Secondary	Electroencephalogram (EEG)	The investigators will compare alpha oscillation power from resting-state EEG recordings before and after stimulation/sham at each session.	Before and after 40-minute stimulation at each session.