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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy
Interventions Device: XCSITE100 Stimulator tACS
Device: XCSITE100 Stimulator Sham
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sham Stimulation, Then Alpha Stimulation Alpha Stimulation, Then Sham Stimulation
Hide 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: Washout Period (5-9 Days)
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Second Session
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Overall Group (Both Sham and Alpha Stimulation)
Hide 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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
5
  25.0%
Male
15
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  20.0%
White
11
  55.0%
More than one race
1
   5.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Salivary Alpha Amylase
Hide Description Change after stimulation
Time Frame Before and after 40-minute stimulation at each session.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Stimulation Alpha Stimulation
Hide 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.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: log-normalized percent change of U/mL
0.00695  (0.196) 0.03055  (0.188)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Stimulation, Alpha Stimulation
Comments [Not Specified]
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 [Not Specified]
2.Primary Outcome
Title Salivary Cortisol
Hide Description Change before and after stimulation
Time Frame Before and after 40 minutes of stimulation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Stimulation Alpha Stimulation
Hide 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.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: log-normalized percent change µg/dL
-0.0551  (0.168) -0.0702  (0.164)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Stimulation, Alpha Stimulation
Comments [Not Specified]
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 [Not Specified]
3.Secondary Outcome
Title Heart Rate Variability
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Stimulation Alpha Stimulation
Hide 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.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: log-normalized percent change
1.599  (3.33) 0.308  (3.70)
4.Secondary Outcome
Title Percent Change in Respiration
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Stimulation Alpha Stimulation
Hide 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.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Percent change in breaths per second
-0.0075  (0.076) 0.0325  (0.093)
5.Secondary Outcome
Title Electroencephalogram (EEG)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Stimulation Alpha Stimulation
Hide 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.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: percent change of uV^2/Hz
-0.0087  (0.0360) 0.0114  (0.0752)
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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham Stimulation Alpha Stimulation
Hide 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 (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sham Stimulation Alpha Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham Stimulation Alpha Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jhana Parikh
Organization: Department of Psychiatry, UNC Chapel Hill
Phone: 919-966-9929
EMail: jhana_parikh@med.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03178344     History of Changes
Other Study ID Numbers: 16-1911a
R01MH111889-01 ( U.S. NIH Grant/Contract )
First Submitted: June 2, 2017
First Posted: June 6, 2017
Results First Submitted: November 7, 2018
Results First Posted: December 7, 2018
Last Update Posted: February 26, 2019