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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH111889-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavio Frohlich, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
IPD will not be shared with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Stimulation, Then Alpha Stimulation | Participants will receive sham stimulation at the first 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. Then, participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes at the first session. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. 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. |
| FG001 | Alpha Stimulation, Then Sham Stimulation | Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes at the first session. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. Then, participants will receive sham 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Session |
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| Washout Period (5-9 Days) |
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| Second Session |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Group (Both Sham and Alpha Stimulation) | Participants received sham stimulation at one session and alpha stimulation at the other in a randomized order. Sessions were separated by 5-9 days. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Salivary Alpha Amylase | Change after stimulation | Posted | Mean | Standard Deviation | log-normalized percent change of U/mL | Before and after 40-minute stimulation at each session. |
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From first session until completion of second session for each participant, for a total of 7-11 days (including both session days and 5-9 days of washout).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Stimulation | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jhana Parikh | Department of Psychiatry, UNC Chapel Hill | 919-966-9929 | jhana_parikh@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2017 | Nov 7, 2018 | Prot_SAP_000.pdf |
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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).
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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.
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| 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. |
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| 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. |
| 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. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Salivary Cortisol | Change before and after stimulation | Posted | Mean | Standard Deviation | log-normalized percent change µg/dL | Before and after 40 minutes of stimulation |
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| 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. | Posted | Mean | Standard Deviation | log-normalized percent change | Before and after 40-minute stimulation at each session. |
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| Secondary | Percent Change in Respiration | Respiration rate, measured via a belt placed around the participant's abdomen as breaths per second. | Posted | Mean | Standard Deviation | Percent change in breaths per second | Before and after 40-minute stimulation at each session. |
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| Secondary | Electroencephalogram (EEG) | The investigators will compare alpha oscillation power from resting-state EEG recordings before and after stimulation/sham at each session. | Posted | Mean | Standard Deviation | percent change of uV^2/Hz | Before and after 40-minute stimulation at each session. |
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| 0 |
| 20 |
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| 20 |
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| 20 |
| EG001 | Alpha Stimulation | 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. 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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