Volumetric Integral Phase-shift Spectroscopy for Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology
NCT ID: NCT03148340
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
287 participants
OBSERVATIONAL
2017-04-14
2018-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VIPS monitoring group
The study population will consist of adult patients presenting for evaluation of acute brain pathology,
VIPS Monitoring
Bioimpedance asymmetry
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VIPS Monitoring
Bioimpedance asymmetry
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Being evaluated for acute ischemic stroke.
3. Able to safely wear the study device for up to 2 minutes per reading.
4. Have NIHSS performed before before study device monitoring.
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cerebrotech Medical Systems, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lyerly Baptist, Inc
Jacksonville, Florida, United States
University of Buffalo
Buffalo, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Smith WS, Lev MH, English JD, Camargo EC, Chou M, Johnston SC, Gonzalez G, Schaefer PW, Dillon WP, Koroshetz WJ, Furie KL. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009 Dec;40(12):3834-40. doi: 10.1161/STROKEAHA.109.561787. Epub 2009 Oct 15.
Nogueira RG, Zaidat OO, Castonguay AC, Haussen DC, Martin CO, Holloway WE, Mueller-Kronast N, English J, Linfante I, Dabus G, Malisch TW, Marden FA, Bozorgchami H, Xavier A, Rai AT, Froehler MT, Badruddin A, Nguyen TN, Taqi MA, Abraham MG, Janardhan V, Yoo AJ, Shaltoni H, Abou-Chebl A, Chen PR, Britz GW, Novakovic R, Nanda A, Kaushal R, Issa MA, Frankel MR, Gupta R. Rescue Thrombectomy in Large Vessel Occlusion Strokes Leads to Better Outcomes than Intravenous Thrombolysis Alone: A 'Real World' Applicability of the Recent Trials. Interv Neurol. 2016 Sep;5(3-4):101-110. doi: 10.1159/000445809. Epub 2016 May 27.
Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.
Saver JL, Goyal M, van der Lugt A, Menon BK, Majoie CB, Dippel DW, Campbell BC, Nogueira RG, Demchuk AM, Tomasello A, Cardona P, Devlin TG, Frei DF, du Mesnil de Rochemont R, Berkhemer OA, Jovin TG, Siddiqui AH, van Zwam WH, Davis SM, Castano C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro A, Lingsma H, Silver FL, Donnan GA, Shuaib A, Brown S, Stouch B, Mitchell PJ, Davalos A, Roos YB, Hill MD; HERMES Collaborators. Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016 Sep 27;316(12):1279-88. doi: 10.1001/jama.2016.13647.
Kodankandath TV, Wright P, Power PM, De Geronimo M, Libman RB, Kwiatkowski T, Katz JM. Improving Transfer Times for Acute Ischemic Stroke Patients to a Comprehensive Stroke Center. J Stroke Cerebrovasc Dis. 2017 Jan;26(1):192-195. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.008. Epub 2016 Oct 12.
Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.
Hastrup S, Damgaard D, Johnsen SP, Andersen G. Prehospital Acute Stroke Severity Scale to Predict Large Artery Occlusion: Design and Comparison With Other Scales. Stroke. 2016 Jul;47(7):1772-6. doi: 10.1161/STROKEAHA.115.012482. Epub 2016 Jun 7.
John S, Stock S, Masaryk T, Bauer A, Cerejo R, Uchino K, Winners S, Rasmussen P, Hussain MS. Performance of CT Angiography on a Mobile Stroke Treatment Unit: Implications for Triage. J Neuroimaging. 2016 Jul;26(4):391-4. doi: 10.1111/jon.12346. Epub 2016 Mar 30.
Rojas R, Rubinsky B, Gonzalez CA. The effect of brain hematoma location on volumetric inductive phase shift spectroscopy of the brain with circular and magnetron sensor coils: a numerical simulation study. Physiol Meas. 2008 Jun;29(6):S255-66. doi: 10.1088/0967-3334/29/6/S22. Epub 2008 Jun 11.
Zuckerman SL, Sivaganesan A, Zhang C, Dewan MC, Morone PJ, Ganesh Kumar N, Mocco J. Maximizing efficiency and diagnostic accuracy triage of acute stroke patients: A case-control study. Interv Neuroradiol. 2016 Jun;22(3):304-9. doi: 10.1177/1591019915622167. Epub 2016 Feb 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CH006
Identifier Type: -
Identifier Source: org_study_id