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

NCT03034902 | Terminated FDA Device

• 1 other identifier: HSC-MS-16-0481
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

Study Arms (1)

Combined EEG and fNIRS

EXPERIMENTAL

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

Interventions

Combined EEG and fNIRS 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

Combined EEG and fNIRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• University of Houston: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paulina B Sergot, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 27, 2017
• Study Start: February 9, 2017
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

US (1)