Effect of tACS Stimulation on Alpha Oscillations

NCT03178344 | Completed Results FDA Device

• 2 other identifiers: 16-1911aR01MH111889-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Salivary Alpha Amylase

  Change after stimulation

  Before and after 40-minute stimulation at each session.

• Salivary Cortisol

  Change before and after stimulation

  Before and after 40 minutes of stimulation

Secondary Outcomes (3)

• Heart Rate Variability

  Before and after 40-minute stimulation at each session.

• Percent Change in Respiration

  Before and after 40-minute stimulation at each session.

• Electroencephalogram (EEG)

  Before and after 40-minute stimulation at each session.

Study Arms (2)

Sham Stimulation, then Alpha Stimulation

EXPERIMENTAL

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.

Device: XCSITE100 Stimulator tACS; Device: XCSITE100 Stimulator Sham

Alpha Stimulation, then Sham Stimulation

EXPERIMENTAL

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.

Device: XCSITE100 Stimulator tACS; Device: XCSITE100 Stimulator Sham

Interventions

XCSITE100 Stimulator tACS 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.

Also known as: tACS

Alpha Stimulation, then Sham Stimulation; Sham Stimulation, then Alpha Stimulation

XCSITE100 Stimulator Sham 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.

Also known as: Sham tACS

Alpha Stimulation, then Sham Stimulation; Sham Stimulation, then Alpha Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65
• Capacity to understand all relevant risks and potential benefits of the study (informed consent)
• Negative pregnancy test for female participants

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Results Point of Contact

• Title: Jhana Parikh
• Organization: Department of Psychiatry, UNC Chapel Hill

jhana_parikh@med.unc.edu

919-966-9929

Study Officials

• Flavio Frohlich, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: August 1, 2017
• Primary Completion: November 4, 2017
• Study Completion: November 4, 2017
• Last Updated: February 26, 2019
• Results First Posted: December 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)