Dementia Signal Development Study of Nautilus NeuroWave TM for the Detection of Dementia

Jan Medical

Status

Completed

Conditions

Alzheimer Disease

Memory Disorders

Mild Cognitive Impairment

Frontotemporal Lobar Degeneration

Treatments

Device: Nautilus NeuroWaveTM System

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02333942

082189

Details and patient eligibility

About

This study is being performed to generate data regarding brain vibration /oscillation differences between individuals with dementia and normal controls. The purpose of this study is to compare signal patterns generated from the impact on the scalp from these brain oscillation patterns from individuals with Alzheimer's disease, Frontotemporal Lobar Degeneration, Mild Cognitive Impairment and Age-Matched Normal Controls.

Full description

This is a non-blinded study in subjects who present to the UCSF Memory and Aging Clinic (MAC) with neurodegenerative disease and cognitive dysfunction. The primary objective of this non-significant risk study is signature development. The goal is to develop a signal algorithm using the Nautilus NeuroWaveTM for dementia. This is accomplished by analyzing and processing Nautilus NeuroWave recordings from a patient with confirmed dementia. All subjects will be enrolled until recordings are obtained from at least 10 of each of the following subject cohorts: Moderate or Severe Frontotemporal Lobar Degeneration (FTDL), Alzheimer's Disease, Mild Cognitive Impairment (MCI) and Age Matched Normal Controls.

As this study is a feasibility study intended to determine whether the Nautilus NeuroWave is able to generate distinctive signals correlated with dementia, statistical analysis will not be required. Similarly, the study has not been powered to attain any particular level of statistical significance. Subsequent studies will measure sensitivity and specificity of any resulting dementia signal pattern generated by this study. These future studies will be subject to statistical analysis.

The Jan Medical Nautilus NeuroWaveTM (NNW) is a non-invasive device designed to evaluate brain oscillation patterns or the brain's pulse, generated by cardiac cycle induced intracranial blood flow. The objective of the evaluation is to determine whether the oscillation pattern is normal, whether it has been disrupted, and, if disrupted, what particular disruption pattern is evident. Various cerebral pathologies studied to date with the NNW demonstrate distinct disruption patterns. These pathologies include vasospasm, concussion and arterio-venous malformation (AVM). The objective of this study is to evaluate the brain oscillation patterns from subjects with MCI, Frontotemporal dementia, AD and from a small cohort of age matched normal controls and determine whether they exhibit pattern disruption and, if so, to quantify and categorize the distinct disruption patterns. How the Nautilus NeuroWave accomplishes this is explained later in the device description section of the protocol.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female subjects 18 years of age or older
Have undergone some neurologic imaging
Age match normal subjects and subjects with symptoms consistent with MCI, FTLD or Alzheimer's disease
Able to understand and provide signed informed consent, or have a legally authorized representative willing to provide informed consent on subject's behalf

Exclusion criteria

Psychologically unstable and not able to cooperate
Not suitable for participation in this study in the opinion of the PI
Patients with history of other cerebral pathologies including, head trauma or prior ICH