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Challenges in TMS-EEG data protocol optimization
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Stroke Subjects | Experimental | Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols |
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| Stroke Subjects | Experimental | Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroencephalogram | Diagnostic Test | A routine test that involves attaching small wires to the head to read the electrical activity of the brain |
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| 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 |
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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:
Exclusion Criteria - Healthy Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Zafer Keser, MD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| D050781 | Transcranial Magnetic Stimulation |
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| Transcranial Magnetic Stimulation | Procedure | 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. |
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| Transcranial Direct Current Stimulation | Procedure | 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. |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D004599 | Electric Stimulation Therapy |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |