Detection of Area of Ischemia in Patients With Subacute Stroke Via a Hybrid EEG-fNIRS Brain-computer Interface

NCT ID: NCT03034902

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-09

Study Completion Date

2017-06-20

Brief Summary

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The purpose of this research study is to determine whether a combined electroencephalography (EEG) and functional near infrared spectroscopy (fNIRS) recording is able to detect changes in brain activity and blood flow after stroke.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Combined EEG and fNIRS

EEG is electroencephalography. fNIRS is functional near infrared spectroscopy. The EEG+NIRS recordings will be obtained via an extended EEG cap that is applied to the subject's head. Changes in neuronal activity and hemodynamics will be measured.

Group Type EXPERIMENTAL

Combined EEG and fNIRS

Intervention Type DEVICE

The EEG+NIRS recordings will be obtained via an extended EEG cap that is applied to the subject's head. Changes in neuronal activity and hemodynamics will be measured. The EEG component is the microEEG by BioSignal Group, UA. The fNIRS component is the NIRScout 24x32, NIRx Medizintechnik GmbH, Germany

Interventions

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Combined EEG and fNIRS

The EEG+NIRS recordings will be obtained via an extended EEG cap that is applied to the subject's head. Changes in neuronal activity and hemodynamics will be measured. The EEG component is the microEEG by BioSignal Group, UA. The fNIRS component is the NIRScout 24x32, NIRx Medizintechnik GmbH, Germany

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients with a subacute ischemic stroke with symptom onset within 8 weeks
* Must have a measurable deficit on the National Institute of Health Stroke Scale (NIHSS)
* Able to give and sign informed consent

Exclusion Criteria

* Aphasia
* Underlying dementia
* Any chronic neurological disorder
* Malignancy
* Non-ambulatory (ambulation with assistance will be included)
* Modified Rankin Score (mRS) \> 3
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Houston

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Paulina Sergot

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulina B Sergot, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-16-0481

Identifier Type: -

Identifier Source: org_study_id

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