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

Primary Purpose

Stroke

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Combined EEG and fNIRS

About this trial

This is an interventional device feasibility trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined EEG and fNIRS

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with abnormal blood flow as assessed by fNIRS

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.

Number of participants with abnormal neuronal activity as assessed by EEG

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03034902

First Posted

January 24, 2017

Last Updated

April 19, 2022

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

University of Houston

1. Study Identification

Unique Protocol Identification Number

NCT03034902

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

The collaborating investigator has moved and cannot collect further data.

Study Start Date

February 9, 2017 (Actual)

Primary Completion Date

June 20, 2017 (Actual)

Study Completion Date

June 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

Collaborators

University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combined EEG and fNIRS

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Combined EEG and fNIRS

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with abnormal blood flow as assessed by fNIRS

Description

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.

Time Frame

immediately at the time of combined EEG and fNIRS for up to 60 minutes

Title

Number of participants with abnormal neuronal activity as assessed by EEG

Description

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.

Time Frame

immediately at the time of combined EEG and fNIRS for up to 60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paulina B Sergot, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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