Effect of Cross Frequency tACS on Cognitive Control
A Pilot Study Investigating the Effects of Cross Frequency Transcranial Alternating Current Stimulation on Cortical Oscillations Underlying Cognition
2 other identifiers
interventional
26
1 country
1
Brief Summary
Investigation of frequency specific transcranial alternating current stimulation on cognitive control signals in frontal cortex
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2018
CompletedFirst Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2019
CompletedResults Posted
Study results publicly available
May 18, 2020
CompletedMay 18, 2020
September 1, 2019
10 months
December 18, 2018
May 1, 2020
May 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Reaction Time for Trials With High Abstraction Relative to Low Abstraction
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
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
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
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
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
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
Study Arms (6)
Theta-gamma, Delta-beta, Sham
EXPERIMENTALEvery 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
Theta-gamma, Sham, Delta-beta
EXPERIMENTALEvery 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
Delta-beta, Theta-gamma, Sham tACS
EXPERIMENTALEvery 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
Delta-beta, Sham, Theta-gamma tACS
EXPERIMENTALEvery 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
Sham, Delta-beta, Theta-gamma tACS
EXPERIMENTALEvery 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
Sham, Theta-gamma, Delta-beta tACS
EXPERIMENTALEvery 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
NeuroConn technologies, direct current-stimulator plus
NeuroConn technologies, direct current-stimulator plus
NeuroConn technologies, direct current-stimulator plus
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Riddle J, McFerren A, Frohlich F. Causal role of cross-frequency coupling in distinct components of cognitive control. Prog Neurobiol. 2021 Jul;202:102033. doi: 10.1016/j.pneurobio.2021.102033. Epub 2021 Mar 16.
PMID: 33741402DERIVED
Results Point of Contact
- Title
- Justin Riddle, PhD
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Flavio Frohlich, PhD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blinded. Neither the investigator nor the participants knows which form of stimulation is received.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2018
First Posted
January 10, 2019
Study Start
October 7, 2018
Primary Completion
July 25, 2019
Study Completion
July 25, 2019
Last Updated
May 18, 2020
Results First Posted
May 18, 2020
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share