TMS-EEG for Cortical Excitability

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05472363
• Other study ID #: 21-012185
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Healthy
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• Electroencephalogram
A routine test that involves attaching small wires to the head to read the electrical activity of the brain

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	MRI based structural connectivity.	Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity.	Baseline

External Links

•   Mayo Clinic Clinical Trials