TMS-EEG for Cortical Excitability

Study Overview
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Brief Summary
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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).

Official Title
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Electroencephalogram Coupled Non-invasive Brain Stimulation For Assessment of Cortical Excitability

Conditions
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Acquired Brain Injury, Stroke, Traumatic Brain Injury, Healthy

Intervention / Treatment
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* Diagnostic Test: Electroencephalogram
* Procedure: Transcranial Magnetic Stimulation
* Procedure: Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Stroke Subjects<br>Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols | Diagnostic Test: Electroencephalogram<br>* A routine test that involves attaching small wires to the head to read the electrical activity of the brain<br>* Other names: EEG;Procedure: Transcranial Magnetic Stimulation<br>* 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.<br>* Other names: TMS;Procedure: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: tDCS;|
| Experimental: Stroke Subjects<br>Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols | Diagnostic Test: Electroencephalogram<br>* A routine test that involves attaching small wires to the head to read the electrical activity of the brain<br>* Other names: EEG;Procedure: Transcranial Magnetic Stimulation<br>* 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.<br>* Other names: TMS;Procedure: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | Baseline | 
| MRI based structural connectivity. | Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity. | Baseline |