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

Sponsor

Jan Medical, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02333942

Collaborator

University of California, San Francisco (Other)

Enrollment

Location

9.1

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Mild Cognitive Impairment Frontotemporal Lobar Degeneration Memory Disorders	Device: Nautilus NeuroWaveTM System

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

41 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

A Non-Blinded, Non-Significant Risk Study With a Non-Invasive, Passive Pressure Wave Method of Diagnosing Brain Pathologies to Develop a Diagnostic Algorithm for Alzheimer Disease and Other Dementias.

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Alzheimer's Disease Nautilus NeuroWaveTM System'	Device: Nautilus NeuroWaveTM System A noninvasive device to detect dementia utilizing headset and sensors
Mild Cognitive Impairment Nautilus NeuroWaveTM System'	Device: Nautilus NeuroWaveTM System A noninvasive device to detect dementia utilizing headset and sensors
Frontotemporal Lobar Degeneration Nautilus NeuroWaveTM System'	Device: Nautilus NeuroWaveTM System A noninvasive device to detect dementia utilizing headset and sensors
Age-Matched Controls Nautilus NeuroWaveTM System'	Device: Nautilus NeuroWaveTM System A noninvasive device to detect dementia utilizing headset and sensors

Outcome Measures

Primary Outcome Measures

Sensitivity as a diagnostic aid in detecting Dementia (identified signatures as compared with the clinical assessment made by the PI) [one year]
Efficacy at identifying Dementia through identified signatures as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive at assessment.
Specificity as a diagnostic aid in detecting Dementia (Rate of false positives as compared with the clinical assessment made by the PI) [one year]
Rate of false positives as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment.

Secondary Outcome Measures

Sensitivity and specificity measures for MCI and Alzheimer's disease (Efficacy and rate of false positives as compared with the clinical assessment made by the PI) [one year]
Efficacy and rate of false positives as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment.
Sensitivity and specificity measures between MCI and FTDL. (distinguish between MCI and FTDL using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI) [one year]
To distinguish between MCI and FTDL using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment.
Sensitivity and specificity measures between FTDL and Alzheimer's disease (distinguish between FTLD and Alzheimer's disease using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI) [one year]
To distinguish between FTLD and Alzheimer's disease using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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