Volumetric Integral Phase-shift Spectroscopy for Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology "VITAL"

Recruiting

Phase N/A Results N/A

Update History

18 Nov '17
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Must be at least 18 years of age. 2. Being evaluated for acute ischemic stroke. 3. Must score 2 or more points on NIHSS question 5. 4. Must be able to safely wear the study device for up to 2 minutes per reading. 5. Must be able to provide written Informed Consent (either self or via an LAR) at any point during the hospital stay, or if unable to provide such consent, must have permission granted by the governing IRB to enroll in the study (i.e., waiver of consent). Exclusion Criteria: - 1. Known or suspected traumatic brain injury, either closed or penetrating. 2. Contraindication to neuroimaging, such as a contrast allergy, or other condition that prohibits CT, MRI, and/or angiography. 3. Presence of any implanted electro-stimulating devices in the head and neck. 4. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh, et cetera. (Note that small metallic objects, such an aneurysm coils, are acceptable.) 5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device. 6. Under arrest or otherwise in custody. 7. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries, etc.). 8. Pregnant or nursing. 9. Any other condition, which in the judgment of the PI would prevent the patient from completing the study or tolerating monitoring sessions and brain imaging, such as mental illness, severe agitation, or hemodynamic instability.
Old
Inclusion Criteria: - 1. Must be at least 18 years of age. 2. Must be undergoing evaluation for acute brain pathology. 3. Must be able to safely wear the study device for up to 2 minutes per reading. 4. Must be able to provide written Informed Consent (either self or via an LAR) at any point during the hospital stay, or if unable to provide such consent, must have permission granted by the governing IRB to enroll in the study (i.e., waiver of consent). Exclusion Criteria: - 1. Known or suspected traumatic brain injury, either closed or penetrating. 2. Contraindication to neuroimaging, such as a contrast allergy, or other condition that prohibits CT, MRI, and/or angiography. 3. Presence of any implanted electro-stimulating devices in the head and neck. 4. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh, et cetera. (Note that small metallic objects, such an aneurysm coils, are acceptable.) 5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device. 6. Under arrest or otherwise in custody. 7. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries, etc.). 8. Pregnant or nursing. 9. Any other condition, which in the judgment of the PI would prevent the patient from completing the study or tolerating monitoring sessions and brain imaging, such as mental illness, severe agitation, or hemodynamic instability.
A location was updated in Jacksonville.
New
The overall status was updated to "Recruiting" at Lyerly Baptist, Inc.
A location was updated in Buffalo.
New
The overall status was updated to "Recruiting" at University of Buffalo.
A location was updated in New York.
New
The overall status was updated to "Recruiting" at The Mount Sinai Hospital.
A location was updated in Charleston.
New
The overall status was updated to "Completed" at Medical University of South Carolina.
A location was updated in Memphis.
New
The overall status was updated to "Not yet recruiting" at University of Tennessee Health Science Center.
26 Jul '17
The eligibility criteria were updated.
New
Inclusion Criteria: - 1. Must be at least 18 years of age. 2. Must be undergoing evaluation for acute brain pathology. 3. Must be able to safely wear the study device for up to 2 minutes per reading. 4. Must be able to provide written Informed Consent (either self or via an LAR) at any point during the hospital stay, or if unable to provide such consent, must have permission granted by the governing IRB to enroll in the study (i.e., waiver of consent). Exclusion Criteria: - 1. Known or suspected traumatic brain injury, either closed or penetrating. 2. Contraindication to neuroimaging, such as a contrast allergy, or other condition that prohibits CT, MRI, and/or angiography. 3. Presence of any implanted electro-stimulating devices in the head and neck. 4. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh, et cetera. (Note that small metallic objects, such an aneurysm coils, are acceptable.) 5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device. 6. Under arrest or otherwise in custody. 7. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries, etc.). 8. Pregnant or nursing. 9. Any other condition, which in the judgment of the PI would prevent the patient from completing the study or tolerating monitoring sessions and brain imaging, such as mental illness, severe agitation, or hemodynamic instability.
Old
Inclusion Criteria: - 1. Must be at least 18 years of age. 2. Must be undergoing evaluation for acute brain pathology. 3. Must be able to safely wear the study device for up to 2 minutes per reading. 4. Must be able to provide written Informed Consent (either self or via an LAR) at any point during the hospital stay, or if unable to provide such consent, must have permission granted by the governing IRB to enroll in the study (i.e., waiver of consent). Exclusion Criteria: - 1. Known or suspected traumatic brain injury, either closed or penetrating. 2. Contraindication to neuroimaging, such as a contrast allergy, or other condition that prohibits CT, MRI, and/or angiography. 3. Presence of any implanted electro-stimulating devices in the head and neck. 4. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh, et cetera. (Note that small metallic objects, such an aneurysm coils, are acceptable.) 5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device. 6. Under arrest or otherwise in custody. 7. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries, etc.). 8. Pregnant or nursing. 9. Any other condition, which in the judgment of the PI would prevent the patient from completing the study or tolerating monitoring sessions and brain imaging, such as mental illness, severe agitation, or hemodynamic instability.
A location was updated in Jacksonville.
New
The overall status was updated to "Recruiting" at Lyerly Baptist, Inc.
A location was updated in Buffalo.
New
The overall status was updated to "Recruiting" at University of Buffalo.
A location was updated in New York.
New
The overall status was updated to "Recruiting" at The Mount Sinai Hospital.
A location was updated in Charleston.
New
The overall status was updated to "Completed" at Medical University of South Carolina.
A location was updated in Memphis.
New
The overall status was updated to "Not yet recruiting" at University of Tennessee Health Science Center.
17 May '17
A location was updated in Jacksonville.
New
The overall status was updated to "Recruiting" at Lyerly Baptist, Inc.
A location was updated in New York.
New
The overall status was updated to "Recruiting" at The Mount Sinai Hospital.