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

Overview

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 Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Device Feasibility
  • Masking: None (Open Label)
• Study Primary Completion Date: June 20, 2017

Interventions

• 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 24×32, NIRx Medizintechnik GmbH, Germany

Arms, Groups and Cohorts

• 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.

Clinical Trial Outcome Measures

Primary Measures

• 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.
• 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • The University of Texas Health Science Center, Houston
• Collaborator
  • University of Houston
• Provider of Information About this Clinical Study
  • Principal Investigator: Paulina Sergot, Assistant Professor – The University of Texas Health Science Center, Houston
• Overall Official(s)
  • Paulina B Sergot, MD, Principal Investigator, The University of Texas Health Science Center, Houston