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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
Participants will be invited back to the second session only if they are able to perform the task. The criteria for demonstrating the cognitive process of interest is that participants must show a benefit to their working memory percent correct during trials with an informative retro-cue relative to trials with an uninformative neutral cue
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
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I am between 18 and 35 years old.
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I showed improvement in memory tasks when given helpful hints.
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I am willing and able to follow all study rules and attend all appointments.

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.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,500 Previous Clinical Trials
4,186,670 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,777 Previous Clinical Trials
2,674,324 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor admit participants over 25 years of age?

"This particular research trial is restricted to individuals between the ages of 18 and 65. However, there are additional medical studies for those under 18 years old (4) and over 65 (6)."

Answered by AI

Are there any open enrollment periods for this scientific experiment?

"The clinical trial is actively enrolling participants, according to the latest update on clinicaltrials.gov. This medical research was originally advertised on January 24th 2022 and has undergone a recent change as of February 18th 2022."

Answered by AI

How many participants are currently being surveyed in this experiment?

"Confirmed. Data hosted on clinicaltrials.gov reveals that this medical trial, which was first published on January 24th 2022, is actively looking for participants. Approximately 48 patients need to be accepted at a single site."

Answered by AI

Might I meet the criteria to join this research endeavor?

"To participate in this medical trial, individuals must possess sound executive function and be within the ages of majority to seniority. At present, 48 participants are being sought after."

Answered by AI
~11 spots leftby Dec 2024