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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

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

Condition or disease Intervention/treatment Phase
Cognitive Control Executive Function Device: Theta-gamma tACS Device: Delta-beta tACS Device: Sham tACS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Official Title: A Pilot Study Investigating the Effects of Cross Frequency Transcranial Alternating Current Stimulation on Cortical Oscillations Underlying Cognition
Actual Study Start Date : October 7, 2018
Actual Primary Completion Date : July 25, 2019
Actual Study Completion Date : July 25, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03800030


Locations
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United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
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: NCT03800030     History of Changes
Other Study ID Numbers: 18-0003
R01MH101547 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of North Carolina, Chapel Hill:
tACS
Cognitive Control
Executive Function