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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03034902
• Other study ID #: HSC-MS-16-0481
• Status: Terminated
• Phase: N/A
• Start date: February 9, 2017
• Est. completion date: June 20, 2017

Study information

• Verified date: April 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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