TMS-EEG for Cortical Excitability

Mayo Clinic

Overview

This research study is being done to look at the safety and diagnostic benefit of conducting an TMS(transcranial magnetic stimulation)-EEG measured before and after a brief experimental stimulation session using investigational devices repetitive TMS or transcranial direct current stimulation (tDCS).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Acquired Brain Injury Stroke Traumatic Brain Injury Healthy

Interventions

ElectroencephalogramDIAGNOSTIC_TEST

A routine test that involves attaching small wires to the head to read the electrical activity of the brain

Transcranial Magnetic StimulationPROCEDURE

Noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain. An electromagnetic coil is placed against the scalp near the forehead. The electromagnet painlessly delivers repetitive magnetic pulses to simulate nerve cells in the brain.

Transcranial Direct Current StimulationPROCEDURE

Noninvasive procedure that uses direct electrical currents to stimulate the brain. A constant, low intensity current is passed through two electrodes that are place on the head.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria - Stroke: \- Acquired brain injury such as ischemic or hemorrhagic stroke or traumatic brain injury. Inclusion Criteria - Healthy Controls: \- No known active neurological disorder. Exclusion Criteria - Stroke: * Pregnancy * Contraindication to MRI or TMS including metallic implanted objects. * Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study. * Severe aphasia. * History of epilepsy. * History of active depression or treatment resistant depression. * History of schizophrenia. Exclusion Criteria - Healthy Controls: * Pregnancy * Contraindication to MRI or TMS including metallic implanted objects. * History of acquired brain injury.

Outcomes

Primary Outcomes

Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ)

Measured using Western Aphasia Battery Bedside Version. Higher score is better. Ranged from 0-100.

Time frame: Baseline, 3 months

Change in Modified Rankin Scale

Measured using the Modified Rankin Scale (MRS) to assess functional outcome measure in stroke that utilizes a structured interview to assign subjects MRS grades 0-5 in a systematic way, grade 5 is severe disability, grade 0 is no symptoms at all

Time frame: Baseline, 3 months

Change in neurological outcome (NIHSS)

Measured using the National Institutes of Health Stroke Scale (NIHSS). 15-item test to assess stroke-related neurologic deficits, each item scored with 3-5 grades with 0 as normal.

Time frame: Baseline, 3 months

EEG and TMS-EEG functional connectivity

EEG power in high and low frequency bands will be measured and power density maps will be created. TMS-evoked potentials and oscillations will be measured.

Time frame: Baseline

MRI based structural connectivity.

Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity.

Time frame: Baseline

Data from ClinicalTrials.gov

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