Cognitive Decline Clinical Trial
Official title:
Evaluation of Cognitive State Using Neurosteer EEG System in Patients Suffering From Cognitive Decline
NCT number | NCT04386902 |
Other study ID # | 042019 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 19, 2019 |
Est. completion date | July 9, 2020 |
Verified date | March 2021 |
Source | Neurosteer Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 9, 2020 |
Est. primary completion date | July 9, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Dorot - Netanya Geriatric Medical Center | Netanya |
Lead Sponsor | Collaborator |
---|---|
Neurosteer Ltd. |
Israel,
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. — View Citation
Goldway N, Ablin J, Lubin O, Zamir Y, Keynan JN, Or-Borichev A, Cavazza M, Charles F, Intrator N, Brill S, Ben-Simon E, Sharon H, Hendler T. Volitional limbic neuromodulation exerts a beneficial clinical effect on Fibromyalgia. Neuroimage. 2019 Feb 1;186:758-770. doi: 10.1016/j.neuroimage.2018.11.001. Epub 2018 Nov 5. — View Citation
Guerrero-Berroa E, Luo X, Schmeidler J, Rapp MA, Dahlman K, Grossman HT, Haroutunian V, Beeri MS. The MMSE orientation for time domain is a strong predictor of subsequent cognitive decline in the elderly. Int J Geriatr Psychiatry. 2009 Dec;24(12):1429-37. doi: 10.1002/gps.2282. — View Citation
Keynan JN, Cohen A, Jackont G, Green N, Goldway N, Davidov A, Meir-Hasson Y, Raz G, Intrator N, Fruchter E, Ginat K, Laska E, Cavazza M, Hendler T. Electrical fingerprint of the amygdala guides neurofeedback training for stress resilience. Nat Hum Behav. 2019 Jan;3(1):63-73. doi: 10.1038/s41562-018-0484-3. Epub 2018 Dec 10. Erratum in: Nat Hum Behav. 2019 Feb;3(2):194. — View Citation
Meir-Hasson Y, Keynan JN, Kinreich S, Jackont G, Cohen A, Podlipsky-Klovatch I, Hendler T, Intrator N. One-Class FMRI-Inspired EEG Model for Self-Regulation Training. PLoS One. 2016 May 10;11(5):e0154968. doi: 10.1371/journal.pone.0154968. eCollection 2016. — View Citation
Meir-Hasson Y, Kinreich S, Podlipsky I, Hendler T, Intrator N. An EEG Finger-Print of fMRI deep regional activation. Neuroimage. 2014 Nov 15;102 Pt 1:128-41. doi: 10.1016/j.neuroimage.2013.11.004. Epub 2013 Nov 15. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and Brain Activity Features Extracted Using the Neurosteer Technology. | Cognition level changes will be evaluated by:
Mini Mental State Examination (MMSE). A commonly used assessment tool that evaluates cognitive functioning and produces a total possible score of 30 points. Patients who score below 24 are typically suspected of cognitive decline. 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 MMSE score. |
MMSE score will be taken from previous evaluation performed in the institute. Through study completion, brain activity features will be assessed using the Neurosteer EEG system, in an average of twice a week. | |
Secondary | Usability and Tolerability of the Neurosteer System in the Elderly Population | Assessment will be conducted by questioning the subject after the test regarding tolerability to remain with the test equipment for the duration of the test and his ability to respond during the test. | 11 months | |
Secondary | Overall Brain Activity in Patients | Brain activity will be measured by the EEG test. Results will be included in statistical analysis that will take into consideration the brain activity as shown in the entire testing period, using power in the known frequency bands (Alpha - Theta). | 11 months | |
Secondary | Overall Response to Auditory Stimulation | Brain activity will be measured by the EEG test, and behavioral results will be measured as well using a clicker. Results will be included in statistical analysis that will take into consideration the brain activity using power in the known frequency bands (Alpha - Theta) as well as subject responses to the auditory stimulation as shown in the entire testing period, using known parameters such as reaction times, accuracy and hit rate. | 11 months |
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