NCT04464473

Brief Summary

The objective of this study is to examine the effect of transcranial magnetic stimulation (TMS) on the prefrontal cortex and posterior parietal cortex.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

2 active sites

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

June 12, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

July 23, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 4, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

June 12, 2020

Results QC Date

March 17, 2025

Last Update Submit

May 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • PFC-PPC Effective Connectivity

    effective connectivity among areas of the prefrontal and posterior parietal cortex in the blood oxygenation level dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) \[note, this measure has no units, but effective connectivity is a rate measure, so is expressed in Hertz\]

    baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)

  • PFC-PPC Activation

    blood oxygenation level dependent (BOLD) signal in areas of the prefrontal and posterior parietal cortex assessed with functional magnetic resonance imaging (fMRI) \[note, this measure has no units\]

    baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)

Secondary Outcomes (6)

  • Temporal Control Performance (Error Rate)

    baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)

  • Contextual Control Performance (Error Rate)

    baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)

  • Temporal x Contextual Control Performance (Error Rate)

    baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)

  • Temporal Control Performance (Reaction Time)

    baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)

  • Contextual Control Performance (Reaction Time)

    baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)

  • +1 more secondary outcomes

Study Arms (3)

FPl-TMS

EXPERIMENTAL

Transcranial magnetic stimulation to the lateral frontal pole. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold.

Device: transcranial magnetic stimulation

MFG-TMS

EXPERIMENTAL

Transcranial magnetic stimulation to the middle frontal gyrus. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold..

Device: transcranial magnetic stimulation

S1-TMS

ACTIVE COMPARATOR

Transcranial magnetic stimulation to primary somatosensory cortex. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold..

Device: transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.

FPl-TMSMFG-TMSS1-TMS

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 30
  • Right-handed
  • Native English speaker or fluent by the age of 6

You may not qualify if:

  • History of psychiatric disorders
  • History of neurological disorders
  • Receiving medications for psychiatric or neurological disorders
  • Familial history of epilepsy
  • Taking any drugs or medications that are pro-epileptic
  • Metal anywhere in the head excluding the mouth
  • Tinnitus
  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida State University Psychology Department Building

Tallahassee, Florida, 32303, United States

Location

FSU MRI Facility

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Results Point of Contact

Title
Dr. Derek Nee
Organization
Florida State University

Study Officials

  • Derek E Nee, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 12, 2020

First Posted

July 9, 2020

Study Start

July 23, 2021

Primary Completion

April 25, 2023

Study Completion

April 25, 2023

Last Updated

June 4, 2025

Results First Posted

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Behavioral and imaging data will be shared

Shared Documents
ANALYTIC CODE
Time Frame
Within a year following publication of findings
Access Criteria
Behavioral and imaging data will be accessible from https://nda.nih.gov/edit\ collection.html?id=3448 by NDA users.

Locations