Causal Role of Delta and Theta Oscillations in Hierarchical Cognitive Control

NCT06734377 | Completed FDA Device

• 1 other identifier: 00005546
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the effect of rhythmic transcranial magnetic stimulation (TMS) delivered at delta (2.2 Hz) or theta (6.5 Hz) frequency on cognitive control. This study aims to explore how targeted stimulation at delta and theta frequencies modulates brain activity to enhance cognitive performance in healthy populations.

Conditions

Rhythmic Transcranial Magnetic Stimulation (rTMS) Effect on Hierarchical Cognitive Control

Keywords

Rhythmic Transcranial Magnetic Stimulation; Hierarchical Cogntive Control

Outcome Measures

Primary Outcomes (1)

• Change in Accuracy

  The Accuracy, reflecting the participants' ability to correctly follow task rules and make accurate judgments based on the given stimulus, is calculated as the percentage of correct responses across trials. The value range is 0% (no correct responses) to 100% (all responses correct), with a larger number denoting more correct responses.

  Baseline (week 1); Session 1 (week 2); Session 2 (week 3)

Secondary Outcomes (3)

• Change in Response Time

  Baseline (week 1); Session 1 (week 2); Session 2 (week 3)

• Change in Amplitude of Neural Oscillations in mid-dlPFC

  Baseline (week 1); Session 1 (week 2); Session 2 (week 3)

• Change in Amplitude of Neural Oscillations in PMd

  Baseline (week 1); Session 1 (week 2); Session 2 (week 3)

Study Arms (2)

TMS to Mid-dlPFC followed by TMS to PMd

EXPERIMENTAL

Participants would receive TMS while performing a cognitive control task. In their first stimulation session, the TMS coil will be placed over mid-dlPFC region on the scalp. In their second session, the TMS coil will be placed over the PMd region on the scalp. During every session, participants receive Delta TMS (2.2 Hz), Theta TMS (6.5 Hz), and Arrhythmic TMS.

Device: Delta TMS; Device: Theta TMS; Device: Arrhythmic TMS

TMS to PMd followed by TMS to Mid-dlPFC

EXPERIMENTAL

Participants would receive TMS while performing a cognitive control task. In their first stimulation session, the TMS coil will be placed over PMd region on the scalp. In their second session, the TMS coil will be placed over the mid-dlPFC region on the scalp. During every session, participants receive Delta TMS (2.2 Hz), Theta TMS (6.5 Hz), and Arrhythmic TMS.

Device: Delta TMS; Device: Theta TMS; Device: Arrhythmic TMS

Interventions

Delta TMS DEVICE

TMS will be administered at the frequency of delta oscillation (2.2Hz)

Also known as: MagPro X100 or R30 system

TMS to Mid-dlPFC followed by TMS to PMd; TMS to PMd followed by TMS to Mid-dlPFC

Theta TMS DEVICE

TMS will be administered at the frequency of theta oscillation (6.5Hz)

Also known as: MagPro X100 or R30 system

TMS to Mid-dlPFC followed by TMS to PMd; TMS to PMd followed by TMS to Mid-dlPFC

Arrhythmic TMS DEVICE

TMS will be administered arrhythmically. In this intervention, the inter-pulse intervals are randomized between delta and theta durations for each trial, ensuring the same total number of pulses but without rhythmic consistency

TMS to Mid-dlPFC followed by TMS to PMd; TMS to PMd followed by TMS to Mid-dlPFC

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be between the ages of 18 and 35.
• Must be able to provide informed consent.
• Must have normal or corrected-to-normal vision.
• Participants must be right-handed.
• Willingness to comply with all study procedures and availability for the study duration.
• Proficiency in speaking and understanding English.

You may not qualify if:

• Must not be color-blind
• Current treatment for ADHD/ADD.
• History of neurological disorders, including but not limited to the following specified conditions
• Epilepsy or seizures (excluding childhood febrile seizures).
• Dementia, Parkinson's disease, multiple sclerosis, cerebral aneurysm, or brain tumors.
• History of stroke or traumatic brain injury.
• Medical conditions or treatments that could interfere with study participation (e.g., unstable cardiac disease, HIV/AIDS, malignancy, or renal impairment).
• Prior brain surgery or presence of brain devices/implants (e.g., cochlear implants or aneurysm clips).
• Females who are pregnant or breastfeeding.
• Use of specific medications, including but not limited to ADHD medications or benzodiazepines, which may interfere with EEG measurements or task performance
• Any condition that, in the opinion of the investigator, increases risk or hinders full compliance with the study.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University Psychology Dept Bldg A411

Tallahassee, Florida, 32304, United States

Location

Related Publications (1)

• Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.

  PMID: 33243615 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant receives all three types of stimulations (delta, theta, arrhythmic) in both brain regions, with the order of stimulation randomized for each session. Across the 12 task blocks in each session with the stimulation, the type of stimulation is interleaved, ensuring that all conditions are represented in a balanced manner. The number of trials for each stimulation condition is counterbalanced within and across blocks to provide equal exposure to each type.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: January 20, 2025
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)