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Effect of Cross Frequency tACS on Cognitive Control

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ClinicalTrials.gov Identifier: NCT03800030
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE January 10, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE October 7, 2018
Actual Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • Delta-beta tACS effect on reaction time during a cognitive control task [ Time Frame: During stimulation, participants perform a cognitive control task. ]
    Delta-beta tACS is hypothesized to decrease reaction time measured by a button press relative to Sham tACS as the abstraction of task demands increase. 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.
  • Theta-gamma tACS effect on reaction time during a cognitive control task. [ Time Frame: During stimulation, participants perform a cognitive control task. ]
    Theta-gamma tACS is hypothesized to decrease reaction time measured by a button press relative to Sham tACS as the set-size, or number of rules, of the task increases. Two of the conditions have fewer rules that must be held in mind, while the level of abstraction is kept consistent.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03800030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • Delta-beta tACS effect on electrical brain activity after stimulation during task. [ Time Frame: In the two-minutes of rest following Delta-beta tACS and task performance. ]
    Delta-beta tACS is hypothesized to increase a measure of cross frequency coupling, i.e. phase amplitude coupling between delta phase and beta amplitude, relative to Sham tACS during a two minute resting state electrical brain recording after performance of the high abstraction cognitive control task block.
  • Theta-gamma tACS effect on electrical brain activity after stimulation during task. [ Time Frame: In the two-minutes of rest following Theta-gamma tACS and task performance. ]
    Theta-gamma tACS is hypothesized to increase a measure of cross frequency coupling, i.e. phase amplitude coupling between theta phase and gamma amplitude, relative to Sham tACS during a two minute resting state electrical brain recording after performance of the high set-size cognitive control task block.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Cross Frequency tACS on Cognitive Control
Official Title  ICMJE A Pilot Study Investigating the Effects of Cross Frequency Transcranial Alternating Current Stimulation on Cortical Oscillations Underlying Cognition
Brief Summary Investigation of frequency specific transcranial alternating current stimulation on cognitive control signals in frontal cortex
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Healthy participants will receive three waveforms of transcranial alternating current stimulation (tACS). Delta-beta, Theta-gamma, and Sham.
Masking: Double (Participant, Investigator)
Masking Description:
Double-blinded. Neither the investigator nor the participants knows which form of stimulation is received.
Primary Purpose: Basic Science
Condition  ICMJE
  • Cognitive Control
  • Executive Function
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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

    Interventions:
    • Device: Theta-gamma tACS
    • Device: Delta-beta tACS
    • Device: Sham tACS
  • 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

    Interventions:
    • Device: Theta-gamma tACS
    • Device: Delta-beta tACS
    • Device: Sham tACS
  • 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

    Interventions:
    • Device: Theta-gamma tACS
    • Device: Delta-beta tACS
    • Device: Sham tACS
  • 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

    Interventions:
    • Device: Theta-gamma tACS
    • Device: Delta-beta tACS
    • Device: Sham tACS
  • 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

    Interventions:
    • Device: Theta-gamma tACS
    • Device: Delta-beta tACS
    • Device: Sham tACS
  • 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

    Interventions:
    • Device: Theta-gamma tACS
    • Device: Delta-beta tACS
    • Device: Sham tACS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 25, 2019
Actual Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03800030
Other Study ID Numbers  ICMJE 18-0003
R01MH101547 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Flavio Frohlich, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP