Effect of Cross Frequency tACS on Cognitive Control

May 1, 2020 updated by: University of North Carolina, Chapel Hill

A Pilot Study Investigating the Effects of Cross Frequency Transcranial Alternating Current Stimulation on Cortical Oscillations Underlying Cognition

Investigation of frequency specific transcranial alternating current stimulation on cognitive control signals in frontal cortex

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous evidence suggests that there are specific frequency bands associated with different aspects of cognitive control. In specific delta (2-4Hz) and beta (15-30Hz) are associated with increased levels of abstraction for learned rules; and theta (5-8Hz) and gamma (30-50Hz) has been associated with increased set-size or number of learned rules. Here we aim to find causal evidence in support of these previous correlational findings by applying cross-frequency transcranial alternating current stimulation (tACS) in the specific frequency bands previously shown to be task-relevant. In a crossover design, we stimulate subjects with either delta-beta or theta-gamma tACS during performance of a hierarchical cognitive control task that manipulates the level of abstraction and set-size of rules that must be learned in order to make the correct button press.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between the ages of 18 and 35 years
  • Able to provide informed consent
  • Willing to comply with all study procedures and be available for the duration of the study Speak and understand English

Exclusion Criteria:

  • Attention Deficit Hyperactivity Disorder (currently under treatment)
  • Neurological disorders and conditions, including, but not limited to:
  • History of epilepsy
  • Seizures (except childhood febrile seizures and electroconvulsive therapy induced seizures) Dementia
  • History of stroke
  • Parkinson's disease
  • Multiple sclerosis
  • Cerebral aneurysm
  • Brain tumors
  • Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, malignancy)
  • Prior brain surgery
  • Any brain devices/implants, including cochlear implants and aneurysm clips
  • History or current traumatic brain injury
  • (For females) Pregnancy or breast feeding
  • Personal or family history of mental/psychiatric disorder (e.g., anxiety, major depressive disorder, schizophrenia, etc.)
  • Positive urine test for the following: Marijuana (THC), Cocaine (COC), Phencyclidine (PCP), Amphetamine (AMP), Ecstasy (MDMA), Methamphetamine (Mamp), Opiates (OPI), Oxycodone (OXY), Methadone (MTD), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Tricyclic Antidepressants (TCA), Propoxyphene (PPX)
  • Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Theta-gamma, Delta-beta, Sham

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS
Device: Theta-gamma tACS
NeuroConn technologies, direct current-stimulator plus
Device: Delta-beta tACS
NeuroConn technologies, direct current-stimulator plus
Device: Sham tACS
NeuroConn technologies, direct current-stimulator plus
Experimental: Theta-gamma, Sham, Delta-beta

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS
Device: Theta-gamma tACS
NeuroConn technologies, direct current-stimulator plus
Device: Delta-beta tACS
NeuroConn technologies, direct current-stimulator plus
Device: Sham tACS
NeuroConn technologies, direct current-stimulator plus
Experimental: Delta-beta, Theta-gamma, Sham tACS

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS
Device: Theta-gamma tACS
NeuroConn technologies, direct current-stimulator plus
Device: Delta-beta tACS
NeuroConn technologies, direct current-stimulator plus
Device: Sham tACS
NeuroConn technologies, direct current-stimulator plus
Experimental: Delta-beta, Sham, Theta-gamma tACS

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS
Device: Theta-gamma tACS
NeuroConn technologies, direct current-stimulator plus
Device: Delta-beta tACS
NeuroConn technologies, direct current-stimulator plus
Device: Sham tACS
NeuroConn technologies, direct current-stimulator plus
Experimental: Sham, Delta-beta, Theta-gamma tACS

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS
Device: Theta-gamma tACS
NeuroConn technologies, direct current-stimulator plus
Device: Delta-beta tACS
NeuroConn technologies, direct current-stimulator plus
Device: Sham tACS
NeuroConn technologies, direct current-stimulator plus
Experimental: Sham, Theta-gamma, Delta-beta tACS

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS
Device: Theta-gamma tACS
NeuroConn technologies, direct current-stimulator plus
Device: Delta-beta tACS
NeuroConn technologies, direct current-stimulator plus
Device: Sham tACS
NeuroConn technologies, direct current-stimulator plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaction Time for Trials With High Abstraction Relative to Low Abstraction
Time Frame: through study completion, an average of 3 weeks
For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis.
through study completion, an average of 3 weeks
Reaction Time for Trials With High Set-size Relative to Low Set-size
Time Frame: through study completion, an average of 3 weeks
The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis.
through study completion, an average of 3 weeks
Delta Phase to Beta Amplitude Coupling Strength
Time Frame: through study completion, an average of 3 weeks
Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution.
through study completion, an average of 3 weeks
Theta Phase to Gamma Amplitude Coupling Strength
Time Frame: through study completion, an average of 3 weeks
Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution.
through study completion, an average of 3 weeks
Percent Correct for Trials With High Abstraction Relative to Low Abstraction
Time Frame: through study completion, an average of 3 weeks
For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis.
through study completion, an average of 3 weeks
Percent Correct for Trials With High Set-size Relative to Low Set-size
Time Frame: through study completion, an average of 3 weeks
The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis.
through study completion, an average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2018

Primary Completion (Actual)

July 25, 2019

Study Completion (Actual)

July 25, 2019

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

January 9, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-0003
  • R01MH101547 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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