AIMS1: Effect of tACS Stimulation on Alpha Oscillations

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT03178344
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: XCSITE100 Stimulator tACS; Device: XCSITE100 Stimulator Sham	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• 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).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
• Official Title: Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 2)
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Nov 4, 2017
• Actual Study Completion Date: Nov 4, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.	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 Names: 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 Names: Sham tACS
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.	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 Names: 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 Names: Sham tACS

Outcome Measures

Primary Outcome Measures

1. Salivary Alpha Amylase [Before and after 40-minute stimulation at each session.]

   Change after stimulation

2. Salivary Cortisol [Before and after 40 minutes of stimulation]

   Change before and after stimulation

Secondary Outcome Measures

1. Heart Rate Variability [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.

2. Percent Change in Respiration [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.

3. Electroencephalogram (EEG) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina Chapel Hill	Chapel Hill	North Carolina	United States	27514

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Flavio Frohlich, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 11, 2017

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03178344
• Other Study ID Numbers: 16-1911a; R01MH111889-01
• First Posted: Jun 6, 2017
• Last Update Posted: Feb 26, 2019
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	Sham Stimulation, Then Alpha Stimulation	Alpha Stimulation, Then Sham Stimulation
Arm/Group Description	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.	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.
Period Title: First Session
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Session
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Session
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Group (Both Sham and Alpha Stimulation)
Arm/Group Description	Participants received sham stimulation at one session and alpha stimulation at the other in a randomized order. Sessions were separated by 5-9 days.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	5 25%
Male	15 75%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 20%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 20%
White	11 55%
More than one race	1 5%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Salivary Alpha Amylase
Description	Change after stimulation
Time Frame	Before and after 40-minute stimulation at each session.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Stimulation	Alpha Stimulation
Arm/Group Description	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.	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.
Measure Participants	20	20
Mean (Standard Deviation) [log-normalized percent change of U/mL]	0.00695 (0.196)	0.03055 (0.188)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham Stimulation, Alpha Stimulation
	Comments
	Type of Statistical Test	Equivalence
	Comments	ANOVA
Statistical Test of Hypothesis	p-Value	0.70
	Comments	P value threshold is 0.05
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Salivary Cortisol
Description	Change before and after stimulation
Time Frame	Before and after 40 minutes of stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Stimulation	Alpha Stimulation
Arm/Group Description	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.	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.
Measure Participants	20	20
Mean (Standard Deviation) [log-normalized percent change µg/dL]	-0.0551 (0.168)	-0.0702 (0.164)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham Stimulation, Alpha Stimulation
	Comments
	Type of Statistical Test	Equivalence
	Comments	ANOVA
Statistical Test of Hypothesis	p-Value	0.71
	Comments	P value threshold is 0.05.
	Method	ANOVA
	Comments

3. Secondary Outcome

Title	Heart Rate Variability
Description	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.
Time Frame	Before and after 40-minute stimulation at each session.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Stimulation	Alpha Stimulation
Arm/Group Description	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.	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.
Measure Participants	20	20
Mean (Standard Deviation) [log-normalized percent change]	1.599 (3.33)	0.308 (3.70)

4. Secondary Outcome

Title	Percent Change in Respiration
Description	Respiration rate, measured via a belt placed around the participant's abdomen as breaths per second.
Time Frame	Before and after 40-minute stimulation at each session.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Stimulation	Alpha Stimulation
Arm/Group Description	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.	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.
Measure Participants	20	20
Mean (Standard Deviation) [Percent change in breaths per second]	-0.0075 (0.076)	0.0325 (0.093)

5. Secondary Outcome

Title	Electroencephalogram (EEG)
Description	The investigators will compare alpha oscillation power from resting-state EEG recordings before and after stimulation/sham at each session.
Time Frame	Before and after 40-minute stimulation at each session.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Stimulation	Alpha Stimulation
Arm/Group Description	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.	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.
Measure Participants	20	20
Mean (Standard Deviation) [percent change of uV^2/Hz]	-0.0087 (0.0360)	0.0114 (0.0752)

Adverse Events

Time Frame	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).
Arm/Group Title	Sham Stimulation		Alpha Stimulation
Arm/Group Description	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.		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.
All Cause Mortality
	Sham Stimulation		Alpha Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Sham Stimulation		Alpha Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Sham Stimulation		Alpha Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.