NCT05204381

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

January 11, 2022

Results QC Date

October 14, 2025

Last Update Submit

November 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Remembered Items

    The number of remembered items, often referred to as working memory capacity, is calculated as the number of items to be remembered (2, 3, or 4) times the hit rate minus the false alarm rate, divided by one minus the false alarm rate. The range of values is 0 to 4 where larger values mean better performance.

    Measured concurrent with stimulation throughout a 3-hour session

  • Strength of Functional Connectivity Between Frontal and Parietal Cortex in Theta-frequency

    Functional connectivity will be measured using weighted phase lag index (wPLI) which is the mean of the imaginary component of the difference in theta-frequency phase between frontal and parietal electrical activity during the second half of the stimulation train for every trial. The values range from 0 to 1 where a greater value represents greater functional connectivity.

    Measured concurrent with stimulation throughout a 3-hour session

Secondary Outcomes (1)

  • Average Phase Lag of Functional Connectivity Between Frontal and Parietal Cortex in Theta-frequency

    Measured concurrent with stimulation throughout a 3-hour session

Study Arms (2)

Theta Stimulation

EXPERIMENTAL

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 and fifth sessions, 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.

Device: Theta-frequency near-zero phase lag stimulationDevice: Theta-frequency anti-synchrony stimulationDevice: Arrhythmic near-zero phase lag stimulationDevice: Arrhythmic independent stimulation

Alpha Stimulation

EXPERIMENTAL

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 and fifth sessions, 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.

Device: Arrhythmic near-zero phase lag stimulationDevice: Arrhythmic independent stimulationDevice: Alpha-frequency near-zero phase lag stimulationDevice: Alpha-frequency anti-synchrony stimulation

Interventions

Rhythmic transcranial magnetic stimulation (TMS) is delivered to both frontal and parietal cortex in theta-frequency (approximately 6 Hz) with a near-zero phase lag.

Theta Stimulation

Rhythmic transcranial magnetic stimulation (TMS) is delivered to both frontal and parietal cortex in theta-frequency (approximately 6 Hz) with a 180 degree phase offset, anti-synchrony.

Theta Stimulation

Rhythmic transcranial magnetic stimulation (TMS) is delivered to both frontal and parietal cortex in an arrhythmic pattern with a near-zero phase lag matched in duration to the rhythmic stimulation for that session.

Alpha StimulationTheta Stimulation

Rhythmic transcranial magnetic stimulation (TMS) is delivered to both frontal and parietal cortex in different independent arrhythmic patterns matched in duration to the rhythmic stimulation for that session.

Alpha StimulationTheta Stimulation

Rhythmic transcranial magnetic stimulation (TMS) is delivered to both frontal and parietal cortex in alpha-frequency (approximately 10 Hz) with a near-zero phase lag.

Alpha Stimulation

Rhythmic transcranial magnetic stimulation (TMS) is delivered to both frontal and parietal cortex in alpha-frequency (approximately 10 Hz) with a 180 degree phase offset, anti-synchrony.

Alpha Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18 and 35
  • Right-handed
  • Able to provide informed consent
  • Have normal to corrected vision without color blindness
  • Willing to comply with all study procedures and be available for the duration of the study Speak and understand English
  • 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

You may not qualify if:

  • Attention Deficit Hyperactivity Disorder (ADHD) (currently under treatment)
  • 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
  • Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment)
  • Prior brain surgery
  • Any brain devices/implants, including cochlear implants and aneurysm clips
  • History of current traumatic brain injury
  • Failure to pass a colorblindness test
  • (For females) Pregnancy or breast feeding
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

Title
Zachary Stewart
Organization
University of North Carollina at Chapel Hill

Study Officials

  • Flavio Frohlich, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 24, 2022

Study Start

January 24, 2022

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

November 20, 2025

Results First Posted

November 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
From 9 to 36 months following publication
Access Criteria
Investigator who proposes to use the data has IRB, IEC, or REB approval and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.

Locations