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Effects of Alpha tACS (PACS)

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ClinicalTrials.gov Identifier: NCT03135639
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

**Follow-up Control Study for Creativity Study

Purpose: To investigate the effect of transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, in healthy subjects. This experiment is a follow-up to previous tACS studies that used a creativity assessment.

Participants: 35 males and females, at least 18 years of age, without history of major psychiatric/neurological disease or associated medication use, or prior brain surgery/implants.

Procedures (methods): This is a cross-over study design. Participants will undergo a control condition of stimulation (sham or individual alpha, 8-12 Hz, tACS) during electroencephalogram recordings. In addition, pupil diameter, heart rate, and respiration will be measured continuously. This is to study the physiological effects of stimulation.


Condition or disease Intervention/treatment Phase
Healthy Other: NeuroConn Plus Stimulator tACS Other: NeuroConn Plus Stimulator Sham Not Applicable

Detailed Description:

Participants will report for a study visit. They will review and sign a consent form.

They will first be fitted with two 5x7cm electrodes placed over occipital and parietal cortex (Cz and Oz). They will also be fitted with ECG electrodes as well as a respiration belt. In addition, they will have a 128-channel EEG net placed on their head and pupillometry glasses. Once the participant is fitted with this equipment, they will complete a 2-minute resting state EEG with their eyes closed to determine their individual alpha frequency. Following the individual alpha frequency determination, the participant will fill out an alertness questionnaire, followed by 3 EEG recordings:

  1. 5 minute before stimulation recording
  2. 20 minute recording during stimulation; either at their individual alpha frequency (between 8 and 12 Hz) or sham stimulation.
  3. 5 minute after stimulation recording

Following these three recordings, the participant will have a 20 minute break in which they will read neutral reading material or converse with the study staff, as well as provide a saliva sample to test for brain derived neurotropic factor (BDNF).

After the 20 minute break, the participant will complete the alertness questionnaire, and the three recordings will be completed again. The participant will then be allowed to clean up, be paid, and leave.

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Clarification for the Experimental Design:

This part of the study is a control condition that will consist of stimulation over occipital and parietal cortex with electrodes over Cz and Oz. Participants will then receive 2mA alternating current stimulation between 8Hz and 12Hz (based on their individual alpha frequency determined by a 2 min eyes closed recording) or sham stimulation for 20 minutes (approximately the duration of the TTCT test) in a resting condition where they will have to focus on a cross hair on a computer screen. EEG will be collected simultaneously during this.

In both conditions, the participants wear a Pupil eye tracking headset, which is commercially available. This allows to monitor eye movements and to obtain physiological relevant measures of the pupil.

To obtain a measure of the heart rate during both conditions, ECG electrodes as part of the EEG acquisition system are placed on the participant's body. Ideally one electrode below the left collarbone and a second below the right chest.

Respiration Effort is measured in both conditions by a SleepSense sleep-lab sensor that is placed with an elastic band over the participants chest and connected to the EEG acquisition system.

Before each session, a questionnaire will be administered to the participant to assess the alertness state.

The entire procedure will be conducted by study personnel with documented training using brain stimulators and EEG.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each participant will receive sham stimulation or stimulation at their individual alpha frequency (8-12 Hz) during a study visit. The order is randomized (i.e., half of participants will receive sham stimulation during the first stimulation session and half will receive sham stimulation during the second stimulation session).
Masking: Double (Participant, Investigator)
Masking Description: This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for creating the stimulation codes that run each session and for ensuring that these codes worked correctly.
Primary Purpose: Basic Science
Official Title: Evaluating Transcranial Alternating Current Stimulation (tACS) for Enhancing Creativity
Actual Study Start Date : August 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sham Stim followed by Alpha Stim

20 minutes of sham stimulation (sham stim) is followed by a washout period of 20 minutes. 20 minutes of alpha stimulation (alpha stim) is applied next.

Sham stimulation mimics the physical effects of stimulation, with up to 1 minute of stimulation during the session. Sham stimulation is delivered using the NeuroConn Plus Stimulator Sham.

Participants will receive 2 mA alternating current stimulation at their individual alpha frequency (8-12 Hz, as determined by the 2 minute resting state EEG) for 20 minutes. Alpha stimulation is delivered using the NeuroConn Plus Stimulator tACS.

Other: NeuroConn Plus Stimulator tACS
Transcranial alternating current stimulation (tACS) is a novel, noninvasive brain stimulation approach in which weak electric currents are applied to the scalp. The electric currents that are applied to the scalp are in a sine-wave pattern.
Other Name: tACS

Other: NeuroConn Plus Stimulator Sham
For sham stimulation, the participant receives up to 1 minute of tACS stimulation until the stimulation fades. This mimics the same skin sensations that a participant would experience during a tACS session.
Other Name: Sham tACS

Experimental: Alpha Stim followed by Sham Stim

20 minutes of alpha stimulation (alpha stim) is followed by a washout period of 20 minutes. 20 minutes of sham stimulation (sham stim) is applied next.

Participants will receive 2 mA alternating current stimulation at their individual alpha frequency (8-12 Hz, as determined by the 2 minute resting state EEG) for 20 minutes. Alpha stimulation is delivered using the NeuroConn Plus Stimulator tACS.

Sham stimulation mimics the physical effects of stimulation, with up to 1 minute of stimulation during the session. Sham stimulation is delivered using the NeuroConn Plus Stimulator Sham.

Other: NeuroConn Plus Stimulator tACS
Transcranial alternating current stimulation (tACS) is a novel, noninvasive brain stimulation approach in which weak electric currents are applied to the scalp. The electric currents that are applied to the scalp are in a sine-wave pattern.
Other Name: tACS

Other: NeuroConn Plus Stimulator Sham
For sham stimulation, the participant receives up to 1 minute of tACS stimulation until the stimulation fades. This mimics the same skin sensations that a participant would experience during a tACS session.
Other Name: Sham tACS




Primary Outcome Measures :
  1. Electroencephalogram power in alpha band [ Time Frame: 5 minute recordings before and after each 20 minute stimulation session during a single study visit. ]
    Changes in the EEG power in the alpha (8-12 Hz) band before and after stimulation sessions.


Secondary Outcome Measures :
  1. Heart Rate Variability [ Time Frame: 5 minute recordings before and after each 20 minute stimulation session during a single study visit. ]
    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. Pupil diameter [ Time Frame: 5 minute recordings before and after each 20 minute stimulation session during a single study visit. ]
    Pupil diameter is associated with arousal. We will look to see what the changes in arousal are before and after stimulation sessions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females at least 18 years of age

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 behavior conditions
  • First degree relative (parent, sibling, child) with neurological or psychiatric illness (past and present)
  • Prior brain surgery
  • Head injury
  • Any brain devices/implants (including cochlear implants and aneurysm clips)
  • Cardiovascular disease
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135639


Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Flavio Frohlich, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03135639     History of Changes
Other Study ID Numbers: 13-3918
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will be available starting from 1 year after publication.
Access Criteria: Data will be available for other publications or other brain stimulation researchers. Sharing is at the discretion of the PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
tACS
transcranial alternating current stimulation
stimulation
healthy control
alpha oscillations
heart rate variability