Transcranial Magnetic Stimulation for Executive Function

(STAR Trial)

Overseen by Flavio Frohlich, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Trial Summary

What is the purpose of this trial?

The participants will perform a cognitive control task. During the task, rhythmic trains of transcranial magnetic stimulation will be delivered to the prefrontal cortex and parietal cortex. Participants will be screened for their ability to perform the task. Magnetic resonance imaging will be used to localize regions of interest to be targeted. Electroencephalography will be collected concurrent with stimulation.

Research Team

Flavio Frohlich, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals aged 18-35 with good English, normal or corrected vision without color blindness, and right-handedness. They must be able to consent, follow the study procedures, and show a working memory benefit from certain cues in a pre-screening task. Pregnant women, those with brain injuries or disorders like epilepsy or ADHD under treatment are excluded.

Inclusion Criteria

I am between 18 and 35 years old.

I showed improvement in memory tasks when given helpful hints.

Able to provide informed consent

Exclusion Criteria

I do not have neurological disorders like epilepsy, dementia, or Parkinson's.

Failure to pass a colorblindness test

I am not pregnant or breastfeeding.

Treatment Details

Interventions

• Theta Connectivity (Behavioural Intervention)

Trial Overview The study tests how different types of rhythmic transcranial magnetic stimulation (TMS) affect cognitive control tasks when applied to specific brain areas. Participants will receive TMS while performing tasks that require executive function skills.

Participant Groups

Group I: Theta Stimulation followed by Alpha Stimulation Experimental Treatment 6 Interventions

Rhythmic transcranial magnetic stimulation (TMS) is delivered to frontal and parietal cortex during performance of a cognitive control task while electroencephalography (EEG) is recorded. In the fourth session, stimulation is delivered in near-zero phase lag theta-frequency, anti-synchrony theta-frequency, near-zero phase lag arrhythmic-in-synchrony stimulation, and arrhythmic-independent stimulation. In the fifth session, stimulation is delivered in near-zero phase lag alpha-frequency, anti-synchrony alpha-frequency, near-zero phase lag arrhythmic-in-synchrony stimulation, and arrhythmic-independent stimulation. The near-zero phase lag arrhythmic-in-synchrony stimulation and arrhythmic-independent stimulation is delivered in both the fourth and fifth session to serve as an active control. Each session is separated by at least one day as a washout period.

Group II: Alpha Stimulation followed by Theta Stimulation Experimental Treatment 6 Interventions

Rhythmic transcranial magnetic stimulation (TMS) is delivered to frontal and parietal cortex during performance of a cognitive control task while electroencephalography (EEG) is recorded. In the fourth session, stimulation is delivered in near-zero phase lag alpha-frequency, anti-synchrony alpha-frequency, near-zero phase lag arrhythmic-in-synchrony stimulation, and arrhythmic-independent stimulation. In the fifth session, stimulation is delivered in near-zero phase lag theta-frequency, anti-synchrony theta-frequency, near-zero phase lag arrhythmic-in-synchrony stimulation, and arrhythmic-independent stimulation. The near-zero phase lag arrhythmic-in-synchrony stimulation and arrhythmic-independent stimulation is delivered in both the fourth and fifth session to serve as an active control. Each session is separated by at least one day as a washout period.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD