TMS-EEG for Cortical Excitability

Not Applicable

Withdrawn

• Conditions: Acquired Brain Injury; Stroke; Traumatic Brain Injury; Healthy

• 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

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• Status: WITHDRAWN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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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