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Effect of tACS Stimulation on Alpha Oscillations (AIMS1)

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ClinicalTrials.gov Identifier: NCT03178344
Recruitment Status : Completed
First Posted : June 6, 2017
Results First Posted : December 7, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE June 2, 2017
First Posted Date  ICMJE June 6, 2017
Results First Submitted Date  ICMJE November 7, 2018
Results First Posted Date  ICMJE December 7, 2018
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date November 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • Salivary Alpha Amylase [ Time Frame: Before and after 40-minute stimulation at each session. ]
    Change after stimulation
  • Salivary Cortisol [ Time Frame: Before and after 40 minutes of stimulation ]
    Change before and after stimulation
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2017)
Saliva [ Time Frame: Before and after 40-minute stimulation at each session. ]
Changes in alpha-amylase and cortisol before and after stimulation. Both alpha-amylase and cortisol and physiological markers of stress that can be measure through saliva.
Change History Complete list of historical versions of study NCT03178344 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • Heart Rate Variability [ Time Frame: Before and after 40-minute stimulation at each session. ]
    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.
  • Percent Change in Respiration [ Time Frame: Before and after 40-minute stimulation at each session. ]
    Respiration rate, measured via a belt placed around the participant's abdomen as breaths per second.
  • Electroencephalogram (EEG) [ Time Frame: Before and after 40-minute stimulation at each session. ]
    The investigators will compare alpha oscillation power from resting-state EEG recordings before and after stimulation/sham at each session.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2017)
  • Heart Rate Variability [ Time Frame: Before and after 40-minute stimulation at each session. ]
    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.
  • Galvanic Skin Response [ Time Frame: Before and after 40-minute stimulation at each session. ]
    Galvanic Skin Response (GSR) is a physiological measure of stress, measured via a weak electrical current passed along a participant's fingertips.
  • Respiration [ Time Frame: Before and after 40-minute stimulation at each session. ]
    Respiration rate is a physiological measure of stress, measured via a belt placed around the participant's abdomen.
  • Electroencephalogram (EEG) [ Time Frame: Before and after 40-minute stimulation at each session. ]
    The investigators will compare alpha oscillation power from resting-state EEG recordings before and after stimulation/sham at each session.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of tACS Stimulation on Alpha Oscillations
Official Title  ICMJE Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 2)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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).
Masking: Double (Participant, Investigator)
Masking Description:
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.
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
    Other Name: tACS
  • 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.
    Other Name: Sham tACS
Study Arms  ICMJE
  • Experimental: 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.

    Interventions:
    • Device: XCSITE100 Stimulator tACS
    • Device: XCSITE100 Stimulator Sham
  • Experimental: 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.

    Interventions:
    • Device: XCSITE100 Stimulator tACS
    • Device: XCSITE100 Stimulator Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 4, 2017
Actual Primary Completion Date November 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03178344
Other Study ID Numbers  ICMJE 16-1911a
R01MH111889-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Flavio Frohlich, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP