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Clinical Trials/NCT05472363
NCT05472363
Withdrawn
Not Applicable

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

Mayo Clinic0 sitesJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acquired Brain Injury
Sponsor
Mayo Clinic
Primary Endpoint
Change in Modified Rankin Scale
Status
Withdrawn
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
July 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zafer Keser

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Modified Rankin Scale

Time Frame: 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

Time Frame: 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.

Time Frame: 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)

Time Frame: Baseline, 3 months

Measured using Western Aphasia Battery Bedside Version. Higher score is better. Ranged from 0-100.

Change in neurological outcome (NIHSS)

Time Frame: 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.

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