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Brain Stimulation Effects on Cognitive Task Performance

Sponsor
Colorado State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05556655
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
22.1
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine optimal task design parameters for the measurement of transcranial magnetic stimulation (TMS) effects on cognition.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation
 N/A

Detailed Description

Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that relies on rapidly changing magnetic fields to influence neuronal firing rates. TMS can be used to temporarily inhibit or enhance the firing of populations of neurons located in the cerebral cortex. TMS-induced cortical inhibition versus enhancement is increasingly being used as a tool for exploring brain-behavior relationships and for improving cognitive functioning in people experiencing cognitive deficits due to neuropsychiatric illness (e.g., dementia and schizophrenia). However, important and unresolved methodological issues in this field concern the optimal design of cognitive tasks for TMS stimulation protocols. The purpose of this study is to determine optimal design protocols for online TMS studies of cognitive processes involved in attention, learning, and memory. Research participants will complete cognitive tasks while active versus sham (i.e., non-stimulating) TMS is applied to the brain. A factorial design will be used to determine the combination of task and TMS parameters (i.e., device settings) that produce the most robust and reliable behavioral effects.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Mechanistic study of impact of transcranial magnetic stimulation (TMS) on cognitive function.Mechanistic study of impact of transcranial magnetic stimulation (TMS) on cognitive function.
Masking:
Single (Participant)
Masking Description:
Participants are blinded to TMS therapy, sham control
Primary Purpose:
Other
Official Title:
Brain Stimulation Effects on Cognitive Task Performance
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active TMS

Repetitive TMS for the brain delivered between 1 and 20 Hz.

Device: Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation (TMS) is a noninvasive method for stimulating neurons (axons not cell bodies) in the brain.
Placebo Comparator: Sham TMS

Scalp stimulation that does not affect the brain.

Device: Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation (TMS) is a noninvasive method for stimulating neurons (axons not cell bodies) in the brain.

Outcome Measures

Primary Outcome Measures

  1. Sternberg Memory Task (Accuracy) [Single study appointment. 1 hour. There will be no follow up.]

    Mean item accuracy on a computerized Sternberg memory task.

  2. Sternberg Memory Task (Reaction Time) [Single study appointment. 1 hour. There will be no follow up.]

    Mean item reaction time on a computerized Sternberg memory task.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Right-handed

  • Fluent in English

Exclusion Criteria:

  • History of seizures or epilepsy

  • Family history of epilepsy

  • Significant medical or neurological diagnoses

  • History of common headache or migraine

  • History of common or recent syncope

  • History of moderate/severe, multiple mild, or past 12 months head injury

  • History of psychiatric, psychological, or neurodevelopmental disorder

  • History of alcohol or recreational drug abuse or dependence

  • Current visual or hearing difficulties that interfere with cognitive testing

  • History of cochlear implants

  • Current pregnancy

  • History of metal in the head or neck (except braces and fillings)

  • Current non-removable piercings in the neck or head

  • History of implanted neurostimulator

  • History of cardiac pacemaker or intracardiac lines

  • History of medication infusion device

  • Current use of medications that increase the excitability of the brain

  • History of problems with TMS or MRI procedures

  • History of EEG for suspected epilepsy

  • Alcohol or recreational drug use in the 48 hours prior to TMS

  • Inadequate sleep in the 48 hours prior to TMS

  • Headache or feeling faint in the 24 hours prior to TMS.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Colorado State University Department of Psychology Fort Collins Colorado United States 80523

Sponsors and Collaborators

  • Colorado State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Colorado State University
ClinicalTrials.gov Identifier:
NCT05556655
Other Study ID Numbers:
  • 3502
First Posted:
Sep 27, 2022
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Colorado State University
Transcranial Magnetic Stimulation
TMS

Study Results

No Results Posted as of Feb 2, 2023