Effect of tACS Stimulation on Alpha Oscillations

NCT ID: NCT03178344

Last Updated: 2019-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
This study will follow a double-blind experimental design, so neither the participant nor the experimenter will know what kind of stimulation the participant is receiving at what session. A separate unblinded monitor, who will not interact with the participants, will be responsible for creating the stimulation codes for each session.

Study Groups

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Sham Stimulation, then Alpha Stimulation

Participants receive sham stimulation at the first session, followed by a 5-9 day washout period and alpha stimulation at the second session.

Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.

Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

Group Type EXPERIMENTAL

XCSITE100 Stimulator tACS

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Alpha Stimulation, then Sham Stimulation

Participants receive alpha stimulation at the first session, followed by a 5-9 day washout period and sham stimulation at the second session.

Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.

Group Type EXPERIMENTAL

XCSITE100 Stimulator tACS

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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tACS Sham tACS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

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: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01MH111889-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-1911a

Identifier Type: -

Identifier Source: org_study_id

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