Clinical trial NCT03178344: Effect of tACS Stimulation on Alpha Oscillations
Official title: Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2017-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will receive sham stimulation or 10 Hz tACS stimulation at two separate sessions. The order will be randomized (ie, half the participants will receive sham stimulation at the first session and 10 Hz tACS stimulation at the second session, and the other half will receive 10 Hz tACS stimulation at the first session and sham stimulation at the second session).
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Salivary Alpha Amylase
timeFrame: Before and after 40-minute stimulation at each session.
measure: Salivary Cortisol
timeFrame: Before and after 40 minutes of stimulation
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: Before and after 40-minute stimulation at each session.
measure: Percent Change in Respiration
timeFrame: Before and after 40-minute stimulation at each session.
measure: Electroencephalogram (EEG)
timeFrame: Before and after 40-minute stimulation at each session.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Flavio Frohlich, PhD
role: PRINCIPAL_INVESTIGATOR
References: