Executive Function Clinical Trial
Official title:
A Pilot Study Investigating the Effects of Cross Frequency Transcranial Alternating Current Stimulation on Cortical Oscillations Underlying Cognition
Verified date | September 2019 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigation of frequency specific transcranial alternating current stimulation on cognitive control signals in frontal cortex
Status | Completed |
Enrollment | 26 |
Est. completion date | July 25, 2019 |
Est. primary completion date | July 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina, Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
Completed |
NCT01365897 -
Effectiveness of Modafinil in Improving Cognitive Performance of University Students
|
Phase 4 | |
Active, not recruiting |
NCT00747396 -
The Bucharest Early Intervention Project
|
N/A | |
Not yet recruiting |
NCT05513339 -
Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows
|
||
Completed |
NCT03003286 -
Community Based Intervention for Children With ADHD and ASD
|
N/A | |
Not yet recruiting |
NCT05468216 -
Movement Integration in Primary Schools' Lessons
|
N/A | |
Completed |
NCT04082247 -
Healthy Children 2021 Study in Childcare Centers
|
N/A | |
Not yet recruiting |
NCT03946254 -
Effect of Strength Training on Executive Functions in Elderly People With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT04989712 -
MOReS Freestyle Libre Validation Study
|
N/A | |
Active, not recruiting |
NCT05290584 -
Influence of Preschool Children's Fundamental Movement Skills, Physical Activity, and Physical Fitness on Executive Function: A Prospective Observation Study
|
||
Recruiting |
NCT06175897 -
Effects of STN DBS on Cognition and Brain Networks in PD Patients Analyzed Based on EEG and fNIRS
|
N/A | |
Not yet recruiting |
NCT04103463 -
Interactive Stepping Exercise on Memory
|
N/A | |
Completed |
NCT03443323 -
Organizational Skills Training
|
N/A | |
Completed |
NCT04329663 -
Effectiveness of the Indonesian Computer-based Game
|
N/A | |
Not yet recruiting |
NCT01718405 -
Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function
|
N/A | |
Recruiting |
NCT06241300 -
Executive Function and Parenting in Childhood
|
N/A | |
Completed |
NCT05910632 -
Eccentrically Reinforced Resistance Training vs. Traditional Resistance Training in Sedentary Older Women
|
N/A | |
Completed |
NCT05462977 -
Rhythmically Entrained Exercise in Community-Dwelling Older Adults
|
N/A | |
Recruiting |
NCT06436209 -
Cognitive Control & the Functional Organization of the Frontal Cortex
|
N/A | |
Not yet recruiting |
NCT06286943 -
The Effects of Short-Chain Fatty Acids in Psychosocial Stress-Induced Impairment on Core Executive Functions
|
N/A |