N/A
N=60
Evaluation of Cognitive State Using Neurosteer EEG System
Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT04386902 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and Brain Activity Features Extracted Using the Neurosteer Technology. — -0.3570; 0.3617 Pearson correlation coefficient
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Neurosteer Aurora system (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Neurosteer Ltd.
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and Brain Activity Features Extracted Using the Neurosteer Technology. |
-0.3570; 0.3617 | — |
| SECONDARY Usability and Tolerability of the Neurosteer System in the Elderly Population |
— | — |
| SECONDARY Overall Brain Activity in Patients |
— | — |
| SECONDARY Overall Response to Auditory Stimulation |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men and women over the age of 45.
- MMSE score < 30.
- MMSE score ≥ 10.
- Patient is able to collaborate.
- No other cognitive comorbidity.
- No seizure event.
Exclusion Criteria
- Advanced stage of cognitive decline (MMSE < 10).
- Any verbal or non-verbal form of objection from patient or form patient's family member or significant other.
- Presence of several cognitive comorbidity.
- Damage to integrity of scalp and/or skull.
- Skin irritation in the facial and forehead area.
- Significant hearing impairments.
- History of drug abuse.
Data sourced from ClinicalTrials.gov (NCT04386902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.