Evaluation of Neurosteer System in Stroke Patients

NCT05524415 | Withdrawn

• 1 other identifier: SCRC18021
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study. Patients who fulfill all inclusion criteria and none of the exclusion criteria will be enrolled in the study, be neurologically evaluated and will go through a series of EEG recordings during their hospitalization. EEG recordings will be analyzed using proprietary computational analyses.

Conditions

Acute Stroke

Keywords

Cognition; Neurology; EEG; Neurosteer; Consciousness

Outcome Measures

Primary Outcomes (1)

• Correlation between consciousness level changes as evaluated by current clinical tools (i.e. GCS) and Brain Activity Features extracted using the Neurosteer technology.

  Consciousness level changes will be evaluated by: 1. Glasgow Coma Scale (GCS). A commonly used assessment tool that evaluates level of consciousness following a traumatic brain injury. The GCS score can range from 3 (completely unresponsive) to 15 (responsive). Generally, the brain injury is classified as: Severe, \< 8-9, Moderate, 9-12 and Mild, ≥ 13. 2. Neurosteer system (single channel EEG recording during cognitive auditory tasks). Using data analysis (a variant of the wavelet packet analysis and the best basis algorithm), the EEG signal is transformed into brain activity features (e.g. ST4, A0). Pearson correlation will be calculated between the mean activity of the EEG features and individual's GCS scores.

  Level of consciousness will be assessed every 4 hours, up to 3 days (72 hours) after joining the study.

Study Arms (1)

Patients

Patients who are hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of acute stroke

Device: Neurosteer EEG recorder

Interventions

Neurosteer EEG recorder DEVICE

The system is composed of hardware and software modules that facilitate the capture and interpretation of electrophysiological data as well as enable viewing the processed data in real time and offline. An electrode patch is attached on the subject's forehead to capture the electrophysiological signal. The signal is sent via low energy Bluetooth to an EEG Monitor. The signal is then sent via Wi-Fi to the cloud where the data is stored on a HIPAA compliant server. Data analysis performed in the cloud transforms the electrophysiological signal into easily readable data of brain activity.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is comprised of patients who are hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of acute stroke.

You may qualify if:

• Men and women over the age of 18.
• Hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of Stroke.
• NIHSS score ≥6.

You may not qualify if:

• Damage to integrity of scalp and/or skull.
• Any verbal or non-verbal form of objection from patient.
• Any verbal or non-verbal form of objection from patient's family member or significant other.

Sponsors & Collaborators

• Neurosteer Ltd.: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

Related Publications (3)

• Molcho L, Maimon NB, Regev-Plotnik N, Rabinowicz S, Intrator N, Sasson A. Single-Channel EEG Features Reveal an Association With Cognitive Decline in Seniors Performing Auditory Cognitive Assessment. Front Aging Neurosci. 2022 May 30;14:773692. doi: 10.3389/fnagi.2022.773692. eCollection 2022.

  PMID: 35707705 BACKGROUND

• Maimon NB, Bez M, Drobot D, Molcho L, Intrator N, Kakiashvilli E, Bickel A. Continuous Monitoring of Mental Load During Virtual Simulator Training for Laparoscopic Surgery Reflects Laparoscopic Dexterity: A Comparative Study Using a Novel Wireless Device. Front Neurosci. 2022 Jan 20;15:694010. doi: 10.3389/fnins.2021.694010. eCollection 2021.

  PMID: 35126032 BACKGROUND

• Curcic J, Vallejo V, Sorinas J, Sverdlov O, Praestgaard J, Piksa M, Deurinck M, Erdemli G, Bugler M, Tarnanas I, Taptiklis N, Cormack F, Anker R, Masse F, Souillard-Mandar W, Intrator N, Molcho L, Madero E, Bott N, Chambers M, Tamory J, Shulz M, Fernandez G, Simpson W, Robin J, Snaedal JG, Cha JH, Hannesdottir K. Description of the Method for Evaluating Digital Endpoints in Alzheimer Disease Study: Protocol for an Exploratory, Cross-sectional Study. JMIR Res Protoc. 2022 Aug 10;11(8):e35442. doi: 10.2196/35442.

  PMID: 35947423 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gal Ifergan

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)