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

April 19, 2022 updated by: Paulina Sergot, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with abnormal blood flow as assessed by fNIRS
Time Frame: immediately at the time of combined EEG and fNIRS for up to 60 minutes
Abnormal blood flow is determined by comparing a part of the patient's brain not affected by stroke to a part of the patient's brain affected by stroke.
immediately at the time of combined EEG and fNIRS for up to 60 minutes
Number of participants with abnormal neuronal activity as assessed by EEG
Time Frame: immediately at the time of combined EEG and fNIRS for up to 60 minutes
Abnormal neuronal activity is determined by comparing a part of the patient's brain not affected by stroke to a part of the patient's brain affected by stroke.
immediately at the time of combined EEG and fNIRS for up to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

University of Houston

Investigators

  • Principal Investigator: Paulina B Sergot, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2017

Primary Completion (Actual)

June 20, 2017

Study Completion (Actual)

June 20, 2017

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-16-0481

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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