TMS-EEG for Cortical Excitability

May 20, 2024 updated by: Zafer Keser, Mayo Clinic

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ)
Time Frame: Baseline, 3 months
Measured using Western Aphasia Battery Bedside Version. Higher score is better. Ranged from 0-100.
Baseline, 3 months
Change in Modified Rankin Scale
Time Frame: 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
Baseline, 3 months
Change in neurological outcome (NIHSS)
Time Frame: 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.
Baseline, 3 months
EEG and TMS-EEG functional connectivity
Time Frame: 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.
Baseline
MRI based structural connectivity.
Time Frame: Baseline
Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Zafer Keser, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (Actual)

July 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-012185

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Electroencephalogram

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe