EEG Analytics to Determine Effectiveness of a tDCS Protocol

NCT03537885 | Completed

• 1 other identifier: BRC493
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to monitor the brain using electroencephalography (EEG) while transcranial direct current stimulation (tDCS) is being administered, as a potential pathway to determine neurophysiological markers capable of forecasting the intensity of a subject's response to tDCS.

Conditions

Healthy; EEG; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Motor Evoked Potential

  A measure of the muscle's responsiveness to non-invasive stimulation.

  Within session

Study Arms (1)

TMS, EEG, and tDCS Group

EXPERIMENTAL

Participants will wear a cap fitted with Electroencephalography (EEG) electrodes to detect the brain's activity during the task. Transcranial Magnetic Stimulation will be used to evaluate the brain's responsiveness to Transcranial Direct Current Stimulation. All study participants will receive the same study procedures - TMS, tDCS, and EEG.

Diagnostic Test: Transcranial Direct Current Stimulation; Diagnostic Test: Transcranial Magnetic Stimulation; Diagnostic Test: Electroencephalography (EEG)

Interventions

Transcranial Direct Current Stimulation DIAGNOSTIC_TEST

Electrodes are placed on that head to deliver a non-invasive brain stimulation to the target area.

TMS, EEG, and tDCS Group

Transcranial Magnetic Stimulation DIAGNOSTIC_TEST

A coil is held tangential to the head in order to deliver a non-invasive brain stimulation to the target area.

TMS, EEG, and tDCS Group

Electroencephalography (EEG) DIAGNOSTIC_TEST

A cap is placed on the head with sensors to detect brain activity during the intervention.

TMS, EEG, and tDCS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurologically healthy

You may not qualify if:

• Ongoing use of CNS-active medications
• Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
• Presence of a potential tDCS/TMS Risk Factor:
• Damaged skin at the site of stimulation (i.e. skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc)
• Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip or any other electrically sensitive support system
• Metal in any part of the body, including metal injury to the eye (Jewelry must be removed during stimulation)
• A history of medication-resistant epilepsy in the family
• Past history of seizures or unexplained spells of loss of consciousness

Sponsors & Collaborators

• Burke Medical Research Institute: lead

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: February 1, 2015
• Primary Completion: June 27, 2018
• Study Completion: December 31, 2018
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)