RECRUITING

Flexibility, Alcohol Misuse, and Excitation

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Conditions

Behavioral FlexibilityHealthy VolunteersHigh Risk Alcohol Usealcoholbrain stimulationMRIEEG

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to learn whether a single non-invasive brain stimulation alpha-transcranial alternating current stimulation (alpha-tACS) session changes measures of excitability in the prefrontal cortex. It will also learn whether these changes predict differences in habitual action selection in a laboratory task and whether the effects depend on alcohol use history. The main questions it aims to answer are: Does alpha-tACS reduce habitual action selection by reducing excitability in the prefrontal cortex? Is alpha-tACS most effective in reducing habitual action selection in hazardous drinkers who engaged in binge-drinking during adolescence? Researchers will compare alpha-tACS to sham stimulation to see if alpha-tACS changes habitual action selection by changing prefrontal excitability. Participants will: Visit the lab for behavioral training Visit the imaging center for an MRI session Visit the lab to receive alpha-tACS or sham stimulation during behavioral testing and undergo EEG recordings before and after stimulation Visit the imaging center for a repeat MRI session Provide a small sample of blood from a finger-prick in the first and last visits.

Official Title

Frontal E/I Balance Mediation of TACS Effects on Behavioral Flexibility

Quick Facts

Study Start:2024-07-18
Study Completion:2027-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06634771

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * • 22-50 years old
  2. * Have a high school diploma or equivalent
  3. * Medically healthy
  4. * Fluent in English
  5. * High risk alcohol use in the past month \[World Health Organization (WHO ) risk level 2-4\]
  6. * No history of adolescent binge drinking
  7. * High risk alcohol use in the past month (WHO risk level 2-4)
  8. * High levels of adolescent alcohol use (4 or more binge drinking episodes before age 18)
  9. * Low risk alcohol use throughout the lifetime (WHO risk level 0-1)
  10. * No history of adolescent binge drinking
  11. * No lifetime history of Alcohol Use Disorder (AUD)
  1. * Any individual who meets one or more of the following criteria will be excluded from participation \[excluding positive breath alcohol concentration (BAC), urine drug screen, psychiatric diagnoses, and color blindness, all will be self-reported\]:
  2. * Lifetime history of a substance use disorder (SUD; including nicotine) but participants will not be excluded for an AUD.
  3. * Neurological disease such as dementia, seizures or head trauma
  4. * History of psychosis or psychotic episodes
  5. * Diagnosis of attention deficit hyperactivity disorder (ADHD)
  6. * Any systemic or inflammatory disease that could affect cognitive functioning (e.g., cancer, cardiovascular disease)
  7. * Any motor or visual disturbances that could hinder task performance (e.g., color blindness)
  8. * Use of psychoactive recreational drugs in the past month (excluding caffeine and alcohol)
  9. * Use of psychotropic medications in the past month including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics (excluding antidepressant use when dosage has been stable for 1 month or longer)
  10. * Use of therapeutic brain stimulation \[e.g. transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT)\] in the past month
  11. * Any history of brain surgery
  12. * History of migraine headaches
  13. * Pregnancy
  14. * Any brain implants or devices
  15. * First degree relative with primary epilepsy
  16. * Claustrophobia
  17. * Any magnetic resonance imaging (MRI) contraindication based on the University of North Carolina Biomedical Research Imaging Center's MRI safety checklist
  18. * Breath alcohol above 0.0% at time of session
  19. * Positive urine drug screen at time of session

Contacts and Locations

Study Contact

Charlotte A Boettiger, PhD
CONTACT
919-962-2119
cab@unc.edu
Grace M Elliott, MS
CONTACT
919-843-9193
gelliott@unc.edu

Principal Investigator

Charlotte A Boettiger, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Charlotte A Boettiger, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-18
Study Completion Date2027-11-30

Study Record Updates

Study Start Date2024-07-18
Study Completion Date2027-11-30

Terms related to this study

Keywords Provided by Researchers

  • alcohol
  • brain stimulation
  • MRI
  • EEG

Additional Relevant MeSH Terms

  • Behavioral Flexibility
  • Healthy Volunteers
  • High Risk Alcohol Use