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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

STAR Trial 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.Check my eligibility
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.See study design
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.

STAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 35 years old.

STAR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of remembered items
Strength of functional connectivity between frontal and parietal cortex in theta-frequency
Secondary outcome measures
Average phase lag of functional connectivity between frontal and parietal cortex in theta-frequency

STAR 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.

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Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,802 Previous Clinical Trials
2,661,568 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,521 Previous Clinical Trials
4,196,582 Total Patients Enrolled
Flavio Frohlich, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
19 Previous Clinical Trials
671 Total Patients Enrolled

Media Library

Theta Connectivity Clinical Trial Eligibility Overview. Trial Name: NCT05204381 — N/A
Executive Function Research Study Groups: Theta Stimulation followed by Alpha Stimulation, Alpha Stimulation followed by Theta Stimulation
Executive Function Clinical Trial 2023: Theta Connectivity Highlights & Side Effects. Trial Name: NCT05204381 — N/A
Theta Connectivity 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204381 — N/A
~8 spots leftby Dec 2024
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