Back to resultsTMS-EEG for Cortical Excitability
Primary Purpose
Acquired Brain Injury, Stroke, Traumatic Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electroencephalogram
Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Acquired Brain Injury
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Non-Stroke Subjects
Stroke Subjects
Arm Description
Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols
Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols
Outcomes
Primary Outcome Measures
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.
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
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.
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.
MRI based structural connectivity.
Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05472363
Brief Title
TMS-EEG for Cortical Excitability
Official Title
Electroencephalogram Coupled Non-invasive Brain Stimulation For Assessment of Cortical Excitability
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Stroke, Traumatic Brain Injury, Healthy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-Stroke Subjects
Arm Type
Experimental
Arm Description
Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols
Arm Title
Stroke Subjects
Arm Type
Experimental
Arm Description
Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols
Intervention Type
Diagnostic Test
Intervention Name(s)
Electroencephalogram
Other Intervention Name(s)
EEG
Intervention Description
A routine test that involves attaching small wires to the head to read the electrical activity of the brain
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ)
Description
Measured using Western Aphasia Battery Bedside Version. Higher score is better. Ranged from 0-100.
Time Frame
Baseline, 3 months
Title
Change in Modified Rankin Scale
Description
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
Time Frame
Baseline, 3 months
Title
Change in neurological outcome (NIHSS)
Description
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.
Time Frame
Baseline, 3 months
Title
EEG and TMS-EEG functional connectivity
Description
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.
Time Frame
Baseline
Title
MRI based structural connectivity.
Description
Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zafer Keser, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zafer Keser
Phone
507-538-1036
Email
keser.zafer@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
TMS-EEG for Cortical Excitability
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