Clinical Trials Logo

Clinical Trial 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 EEG recordings while listening to an auditory cognitive assessment tool and preforming tasks. EEG recordings will be analyzed using proprietary computational analyses.


Clinical Trial Description

One of the major problems in the prevention and treatment of neurological disorders, is the lack of cost effective and reliable tools to assess neurodegeneration on a large scale at a very early stage. Although current imaging methods give a clear image of the brain atrophy involved in neurodegenerative disorders, there are deficiencies prohibiting their usage for prevention-scanning of large high-risk population such as high price, long set-up time and the need for trained personnel to conduct the test. Therefore, the development of a reliable tool to assess brain neurodegeneration, associated with cognitive decline independent of personal interpretation and/or variance between clinicians and between medical facilities would be highly valuable. This tool would allow the healthcare team to make appropriate treatment decisions that could aid in neurodegenerative disease prevention. The Neurosteer system provides objective neurological biomarkers using a wearable easy-to-use affordable system. The system facilitate the capture and interpretation of EEG data with only a single patch of electrodes, attached on the subject's forehead. Neurosteer examination includes completing auditory tasks while measuring brain activity with the device. The data is analyzed using machine learning methods to produce biomarkers, enabling a report of the patient's activity in real time and offline. The examination is easy to preform and can be conducted in every clinic or in patients' homes. In this study, clinical staff will identify potential subjects and will examine the eligibility of subject according to inclusion and exclusion criteria. Research staff will inform the patient on study's objective and design. Patients will sign the Informed Consent Form (ICF). Research staff will set up an assessment session using the Neurosteer system. In this session the patient will listen to the auditory assessment battery and perform cognitive tasks. Over the next 7 days, clinical staff will set up another session using the Neurosteer system. In this session the patient will listen to auditory instructions and perform two PASS sub-tasks: a drug sorting task and a phone use task. Level of cognition will be assessed by validated screening tools (MMSE and MoCA) and the Neurosteer technology. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05528445
Study type Observational
Source Neurosteer Ltd.
Contact
Status Completed
Phase
Start date May 31, 2022
Completion date August 27, 2023

See also
  Status Clinical Trial Phase
Completed NCT03228446 - The Effects of Attentional Filter Training on Working Memory N/A
Completed NCT04033419 - Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer Phase 2
Terminated NCT05199142 - A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline Phase 1
Active, not recruiting NCT05290233 - Time Restricted Eating Plus Exercise for Weight Management N/A
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Unknown status NCT00696514 - Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People Phase 1
Completed NCT00110604 - The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing N/A
Recruiting NCT06245005 - Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
Recruiting NCT05014399 - Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Active, not recruiting NCT05586750 - Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy Phase 4
Completed NCT04386902 - Evaluation of Cognitive State Using Neurosteer EEG System
Recruiting NCT06070818 - Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline N/A
Completed NCT01669915 - A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline N/A
Completed NCT02814526 - Exercise in Adults With Mild Memory Problems N/A
Not yet recruiting NCT06252376 - Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in PD N/A
Not yet recruiting NCT05928078 - A Home-based e-Health Intervention in the Elderly: MOVI-ageing N/A
Recruiting NCT06318377 - Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals N/A
Recruiting NCT03839784 - Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Completed NCT04537728 - My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices N/A
Active, not recruiting NCT03370796 - Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context N/A