N/A
N=77
Evaluation of Cognitive State in Seniors Using Neurosteer EEG System
Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT05528445 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE, MoCA) and Brain Activity Features Extracted Using the Neurosteer Technology. — -0.27; -0.26 Pearson correlation coefficient
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Neurosteer EEG recorder (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Neurosteer Ltd.
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE, MoCA) and Brain Activity Features Extracted Using the Neurosteer Technology. |
-0.27; -0.26 | — |
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 50.
- MMSE ≥ 10
- Patient is able to collaborate.
- No seizure events.
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.
- Significant hearing impairments.
- Significant vision impairments.
- Damage to integrity of scalp and/or skull.
- Skin irritation in the facial and forehead area.
- Epilepsy or seizure activity.
- History of drug abuse.
Data sourced from ClinicalTrials.gov (NCT05528445). 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.