NCT03800030

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 18, 2020

Completed
Last Updated

May 18, 2020

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

December 18, 2018

Results QC Date

May 1, 2020

Last Update Submit

May 1, 2020

Conditions

Keywords

tACSCognitive ControlExecutive Function

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

EXPERIMENTAL

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 tACSDevice: Delta-beta tACSDevice: Sham tACS

Theta-gamma, Sham, Delta-beta

EXPERIMENTAL

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 tACSDevice: Delta-beta tACSDevice: Sham tACS

Delta-beta, Theta-gamma, Sham tACS

EXPERIMENTAL

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 tACSDevice: Delta-beta tACSDevice: Sham tACS

Delta-beta, Sham, Theta-gamma tACS

EXPERIMENTAL

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 tACSDevice: Delta-beta tACSDevice: Sham tACS

Sham, Delta-beta, Theta-gamma tACS

EXPERIMENTAL

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 tACSDevice: Delta-beta tACSDevice: Sham tACS

Sham, Theta-gamma, Delta-beta tACS

EXPERIMENTAL

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 tACSDevice: Delta-beta tACSDevice: Sham tACS

Interventions

NeuroConn technologies, direct current-stimulator plus

Delta-beta, Sham, Theta-gamma tACSDelta-beta, Theta-gamma, Sham tACSSham, Delta-beta, Theta-gamma tACSSham, Theta-gamma, Delta-beta tACSTheta-gamma, Delta-beta, ShamTheta-gamma, Sham, Delta-beta

NeuroConn technologies, direct current-stimulator plus

Delta-beta, Sham, Theta-gamma tACSDelta-beta, Theta-gamma, Sham tACSSham, Delta-beta, Theta-gamma tACSSham, Theta-gamma, Delta-beta tACSTheta-gamma, Delta-beta, ShamTheta-gamma, Sham, Delta-beta
Sham tACSDEVICE

NeuroConn technologies, direct current-stimulator plus

Delta-beta, Sham, Theta-gamma tACSDelta-beta, Theta-gamma, Sham tACSSham, Delta-beta, Theta-gamma tACSSham, Theta-gamma, Delta-beta tACSTheta-gamma, Delta-beta, ShamTheta-gamma, Sham, Delta-beta

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

Results Point of Contact

Title
Justin Riddle, PhD
Organization
University of North Carolina at Chapel Hill

Study Officials

  • Flavio Frohlich, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

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
Model Details: Healthy participants will receive three waveforms of transcranial alternating current stimulation (tACS). Delta-beta, Theta-gamma, and Sham.
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

Locations