Acquired Brain Injury, Healthy, Stroke, Traumatic Brain Injury
Conditions
Brief summary
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).
Interventions
DIAGNOSTIC_TESTElectroencephalogram
A routine test that involves attaching small wires to the head to read the electrical activity of the brain
PROCEDURETranscranial Magnetic Stimulation
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.
PROCEDURETranscranial Direct Current Stimulation
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.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ) | Baseline, 3 months | Measured using Western Aphasia Battery Bedside Version. Higher score is better. Ranged from 0-100. |
| Change in Modified Rankin Scale | Baseline, 3 months | 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 |
| Change in neurological outcome (NIHSS) | Baseline, 3 months | 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. |
| EEG and TMS-EEG functional connectivity | Baseline | 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. |
| MRI based structural connectivity. | Baseline | Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity. |
Outcome results
None listed