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Transcranial Magnetic Stimulation for Executive Function (STAR Trial)

N/A

Recruiting

Led By Flavio Frohlich, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 18 and 35

Be older than 18 years old

Must not have

Neurological disorders and conditions, including, but not limited to: History of epilepsy, Seizures (except childhood febrile seizures), Dementia, History of stroke, Parkinson's disease, Multiple sclerosis, Cerebral aneurysm, Brain tumors

(For females) Pregnancy or breast feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether transcranial magnetic stimulation can improve cognitive control by delivering stimulation to the prefrontal cortex and parietal cortex.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated here, common side effects of TMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms in facial muscles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not pregnant or breastfeeding.

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I am currently being treated for ADHD.

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I have had brain surgery before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of remembered items

Strength of functional connectivity between frontal and parietal cortex in theta-frequency

Secondary study objectives

Average phase lag of functional connectivity between frontal and parietal cortex in theta-frequency

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Theta Stimulation followed by Alpha StimulationExperimental Treatment6 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 StimulationExperimental Treatment6 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.

0 / 5Eligibility criteria met