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TMS-EEG for Cortical Excitability

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05472363
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
48
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Electroencephalogram
  • Procedure: Transcranial Magnetic Stimulation
  • Procedure: Transcranial Direct Current Stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Electroencephalogram Coupled Non-invasive Brain Stimulation For Assessment of Cortical Excitability
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Non-Stroke Subjects

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
A routine test that involves attaching small wires to the head to read the electrical activity of the brain
Other Names:
  • EEG

    • Procedure: Transcranial 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.
    Other Names:
  • TMS

    • Procedure: Transcranial 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.
    Other Names:
  • tDCS

    		•
    Experimental: Stroke Subjects

    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
    A routine test that involves attaching small wires to the head to read the electrical activity of the brain
    Other Names:
  • EEG

    • Procedure: Transcranial 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.
    Other Names:
  • TMS

    • Procedure: Transcranial 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.
    Other Names:
  • tDCS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    3. 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.

    4. 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.

    5. MRI based structural connectivity. [Baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Exclusion Criteria - Healthy Controls:

    • Pregnancy

    • Contraindication to MRI or TMS including metallic implanted objects.

    • History of acquired brain injury.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Zafer Keser, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Zafer Keser, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05472363
    Other Study ID Numbers:
    • 21-012185
    First Posted:
    Jul 25, 2022
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 25, 2022