- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333942
Dementia Signal Development Study of Nautilus NeuroWave TM for the Detection of Dementia
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94143
- University of Californa San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Alzheimer's Disease
Nautilus NeuroWaveTM System'
|
A noninvasive device to detect dementia utilizing headset and sensors
|
Mild Cognitive Impairment
Nautilus NeuroWaveTM System'
|
A noninvasive device to detect dementia utilizing headset and sensors
|
Frontotemporal Lobar Degeneration
Nautilus NeuroWaveTM System'
|
A noninvasive device to detect dementia utilizing headset and sensors
|
Age-Matched Controls
Nautilus NeuroWaveTM System'
|
A noninvasive device to detect dementia utilizing headset and sensors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one year
|
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.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one year
|
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.
|
one year
|
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.
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aimee Kao, MD, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Tauopathies
- Cognition Disorders
- Dementia
- Alzheimer Disease
- Cognitive Dysfunction
- Memory Disorders
- Frontotemporal Lobar Degeneration
Other Study ID Numbers
- 082189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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