Brain Stimulation Effects on Cognitive Task Performance

Cognitive Function Clinical Trial

Official title:

Brain Stimulation Effects on Cognitive Task Performance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556655
• Other study ID #: 3502
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: Colorado State University
• Contact: Michael Thomas, PhD
• Phone: (970) 491-6820
• Email: Michael.L.Thomas[@]colostate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Function

Intervention

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

Locations

Country	Name	City	State
United States	Colorado State University Department of Psychology	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sternberg Memory Task (Accuracy)	Mean item accuracy on a computerized Sternberg memory task.	Single study appointment. 1 hour. There will be no follow up.
Primary	Sternberg Memory Task (Reaction Time)	Mean item reaction time on a computerized Sternberg memory task.	Single study appointment. 1 hour. There will be no follow up.