TMS-EEG for Cortical Excitability

NCT05472363 | Withdrawn FDA Device

• 1 other identifier: 21-012185
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acquired Brain Injury; Stroke; Traumatic Brain Injury; Healthy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• MRI based structural connectivity.

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

  Baseline

Study Arms (2)

Non-Stroke Subjects

EXPERIMENTAL

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; Procedure: Transcranial Magnetic Stimulation; Procedure: Transcranial Direct Current Stimulation

Stroke Subjects

EXPERIMENTAL

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; Procedure: Transcranial Magnetic Stimulation; Procedure: Transcranial Direct Current Stimulation

Interventions

Electroencephalogram DIAGNOSTIC_TEST

A routine test that involves attaching small wires to the head to read the electrical activity of the brain

Also known as: EEG

Non-Stroke Subjects; Stroke Subjects

Transcranial Magnetic Stimulation PROCEDURE

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.

Also known as: TMS

Non-Stroke Subjects; Stroke Subjects

Transcranial Direct Current Stimulation PROCEDURE

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.

Also known as: tDCS

Non-Stroke Subjects; Stroke Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Acquired brain injury such as ischemic or hemorrhagic stroke or traumatic brain injury.
• \- No known active neurological disorder.

You may not qualify if:

• 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.
• Pregnancy
• Contraindication to MRI or TMS including metallic implanted objects.
• History of acquired brain injury.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Injuries; Stroke; Brain Injuries, Traumatic

Interventions

Electroencephalography; Transcranial Magnetic Stimulation; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetic Field Therapy; Therapeutics; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Zafer Keser, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 25, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-05