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

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ClinicalTrials.gov Identifier: NCT02333942
Recruitment Status : Unknown
Verified June 2015 by Jan Medical, Inc..
Recruitment status was:  Active, not recruiting
First Posted : January 8, 2015
Last Update Posted : June 4, 2015
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Jan Medical, Inc.

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
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 Type : Observational
Estimated Enrollment : 40 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.
Study Start Date : May 2014
Actual Primary Completion Date : February 2015
Estimated Study Completion Date : March 2016


Group/Cohort 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




Primary Outcome Measures :
  1. Sensitivity as a diagnostic aid in detecting Dementia (identified signatures as compared with the clinical assessment made by the PI) [ Time Frame: 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.

  2. Specificity as a diagnostic aid in detecting Dementia (Rate of false positives as compared with the clinical assessment made by the PI) [ Time Frame: 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 :
  1. 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) [ Time Frame: 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.

  2. 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) [ Time Frame: 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.

  3. 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) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with Alzheimer's Disease, Frontotemporal Lobar Degeneration, Mild Cognitive Impairment, and Age-Matched Controls.
Criteria

Inclusion Criteria:

  1. Male or female subjects 18 years of age or older
  2. Have undergone some neurologic imaging
  3. Age match normal subjects and subjects with symptoms consistent with MCI, FTLD or Alzheimer's disease
  4. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333942


Locations
United States, California
University of Californa San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Jan Medical, Inc.
University of California, San Francisco
Investigators
Principal Investigator: Aimee Kao, MD, PhD University of California, San Francisco

Responsible Party: Jan Medical, Inc.
ClinicalTrials.gov Identifier: NCT02333942     History of Changes
Other Study ID Numbers: 082189
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Jan Medical, Inc.:
Aging
Diagnostic Equipment

Additional relevant MeSH terms:
Dementia
Frontotemporal Lobar Degeneration
Alzheimer Disease
Cognitive Dysfunction
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases