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

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Device: Combined EEG and fNIRS

• Registration Number: NCT03034902
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Study Start: 2017-02-09
• Primary Completion: 2017-06-20
• Study Completion: 2017-06-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined EEG and fNIRS	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal neuronal activity as assessed by EEG	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.
Number of participants with abnormal blood flow as assessed by fNIRS	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States