TMS-EEG for Cortical Excitability

Not Applicable

Withdrawn

• Conditions: Acquired Brain Injury; Stroke; Traumatic Brain Injury; Healthy
• Interventions: Diagnostic Test: Electroencephalogram; Procedure: Transcranial Magnetic Stimulation; Procedure: Transcranial Direct Current Stimulation

• Registration Number: NCT05472363
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stroke Subjects	Electroencephalogram	Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols
Stroke Subjects	Transcranial Magnetic Stimulation	Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols
Stroke Subjects	Transcranial Direct Current Stimulation	Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols
Non-Stroke Subjects	Transcranial Magnetic Stimulation	Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols
Non-Stroke Subjects	Electroencephalogram	Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols
Non-Stroke Subjects	Transcranial Direct Current Stimulation	Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols

Primary Outcome Measures

Name	Time	Method
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.
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.
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
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.
MRI based structural connectivity.	Baseline	Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity.