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Clinical Trials

MainTitle

Prevalence of HIV-associated Neurocognitive Disorders (HAND) in a School of Medicine HIV/AIDS Outpatient Clinic (HAND)

This study has been completed
Sponsor
East Tennessee State University

Collaborator
Neuronetrix, Inc.

Information provided by (Responsible Party)
Dr. Norman Moore, East Tennessee State University

ClinicalTrials.gov Identifier
NCT02187796

First received: July 9, 2014
Last updated: August 3, 2015
Last Verified: August 2015
History of Changes
Purpose

Purpose

1. To determine, in the Quillen College of Medicine HIV+ outpatient clinic, the prevalence of

  • NC (normal cognition )
  • ANI (asymptomatic neurocognitive impairment )
  • MCD (mild cognitive disorder )
  • HAD (HIV-associated dementia )
  • To determine whether the following variables affect the three categories of HAND
    • Time since first diagnosis of HIV infection
    • Anti-viral medications used
    • Age
    r

    Condition
    HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)

    Study Type: Observational
    Study Design: Observational Model: Case Control
    Time Perspective: Cross-Sectional
    Official Title: PREVALENCE of HIV-ASSOCIATED NEUROCOGNITIVE DISORDERS (HAND) in a SCHOOL of MEDICINE HIV/AIDS OUTPATIENT CLINIC

    Further study details as provided by Dr. Norman Moore, East Tennessee State University:

    Primary Outcome Measures

    • IntegNeuro [ Time Frame: at enrollment ]
      IntegNeuro is a touch-screen computerized neuropsychological assessment tool which tests the following cognitive domains: Motor Tapping Choice Reaction Time Time Estimation Word Generation Digit Span Memory recall & Recognition Spot the Word Span of Visual Memory Continuous Performance Test Verbal Interference Switching of Attention Maze Go/No-Go Emotion Processing
    • IADL (Instrumental Activities of Daily Living Scale) [ Time Frame: at enrollment ]
      HAND criteria include normal activities of daily living for NC and ANI, and impairment of these activities in MCD and HAD. The Instrumental Activities of Daily Living Scale will determine whether the cognitive impairment is interfering with work, home life, social activity or other activities of daily living. The maximum IADL score of 8, means no impairment in any of the following 8 activities; telephoning, shopping, preparing food, housekeeping, laundry, travel, medications and finances. A score of 7 or less will indicate impairment.
    • Medical Outcomes Study HIV (MOS-HIV) Health Survey [ Time Frame: at enrollment ]
      The Medical Outcomes Study HIV (MOS-HIV) Health Survey is a widely used instrument to assess quality of life in HIV-1-infected individuals. Its cognitive functional status subscale measures functional status owing to neuropsychological (NP) impairment.
    Secondary Outcome Measures:
    • MMSE (Mini Mental State Exam) [ Time Frame: at enrollment ]
      The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment.
    • COGNISION P300 ODD- BALL DEVICE [ Time Frame: at enrollment ]
      The P300 is evoked by an "oddball' sound of high pitch and irregular timing, compared with sound of lower pitch and regular timing. The subject is asked to count oddball and ignore regular sounds. The P300 is a positive waveform, usually at 300 milliseconds after the oddball sensory input. The COGNISION System is an electroencephalographic (EEG) device that records microvolt level voltage potentials from the subject's scalp. It collects electrophysiological responses to external auditory stimuli, such as in the P300 paradigm. It is composed of (1) a Headset Assembly to be placed on the subject's head at the time of the test, (2) a handheld Headset Control Unit (HCU) to operate the device, (3) computer software to order and monitor the test and analyze the test results, (4) standard stereo earphones (for auditory ERPs).

    Enrollment: 50
    Study Start Date: May 2014
    Study Completion Date: June 2015
    Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

    Arms
    Normal Cognition
    HIV+ individuals with no detectable neurocognitive impairment
    ANI (asymptomatic neurocognitive impairment)
    HIV+ individuals where impairment involves at least two cognitive domains, and results in neuropsychological testing performance at least 1 Standard Deviation (SD) below the appropriate mean age/education norm for: Information processing speed Sensory/motor skills Short-term and long-term memory Ability to learn new skills and solve problems Attention, concentration, and distractibility Logical and abstract reasoning functions Ability to understand and express language Visual-spatial organization Visual-motor coordination Planning, synthesizing and organizing abilities
    MCD (Mild Cognitive Disorder)
    HIV+ individuals with cognitive impairment same as ANI but patient or caregivers report that cognitive deficit interferes with mental acuity, work efficiency, home making or social activity
    HAD (HIV-associated dementia)
    HIV+ individuals where impairment involves at least two cognitive domains and results in neuropsychological testing at least 2 SD below the appropriate mean age/education norm for: Information processing speed Short-term and long-term memory Ability to learn new skills and solve problems Attention, concentration, and distractibility Logical and abstract reasoning functions Ability to understand and express language Visual-spatial organization Visual-motor coordination Planning, synthesizing and organizing abilities Cognitive impairment significantly interferes with work, home life, social activities or ADL's.
    Healthy Controls (HIV-)
    Our P300 COGNISION apparatus has been used only in subjects over the age of 60, whereas our participants in the HAND study will all be younger than 60. So, we cannot use COGNISION normative data base for comparison. We will add 10 HIV- healthy controls to our planned 40 HIV+ subjects. These HIV- participants will be age- and gender-matched to the HIV- Asymptomatic Neurocognitive Impairment (ANI) patients, and will undergo all the same assessments

    Detailed Description:

    As life expectancy increases, dementia becomes more common, and the need for its correct diagnosis and treatment becomes more urgent. Alzheimer's disease (AD) is the leading cause of dementia, but its diagnosis is by exclusion of all other causes. Successful treatment of HIV/AIDS has resulted in more patients living long enough to develop HIV-Associated Neurocognitive Disorders (HAND), including dementia.


  • The National Institute of Mental Health, and the National Institute of Neurological Diseases and Stroke, updated standards for diagnosing HAND. The new criteria created an additional category, HIV-associated asymptomatic neurocognitive impairment (ANI), and modified the name and criteria for what was called MCMD (minor cognitive/motor disorder) to mild cognitive disorder (MCD). HIV-associated dementia (HAD) remained unchanged. Their definition of HAND includes: Cognitive impairment must be attributable to HIV and no other etiology (Dementia, Delirium, Depression, CNS neoplasm, CNS infection other than HIV/AIDS. Cerebrovascular disease, Substance abuse). Their criteria state that cognitive impairment should be validated by neuropsychological testing.
    The three categories of HAND are:
    1. HIV-associated asymptomatic neurocognitive impairment (ANI)

    Impairment involves at least two cognitive domains, and results in neuropsychological testing performance at least 1 Standard Deviation (SD) below the appropriate mean age/education norm for:
    • Information processing speed
    • Sensory/motor skills
    • Short-term and long-term memory
    • Ability to learn new skills and solve problems
    • Attention, concentration, and distractibility
    • Logical and abstract reasoning functions
    • Ability to understand and express language
    • Visual-spatial organization Visual-motor coordination
    • Planning, synthesizing and organizing abilities
  • Mild Cognitive Disorder (MCD) Same as ANI but patient or caregivers report that cognitive deficit interferes with mental acuity, work efficiency, home making or social activity
  • HIV-associated dementia (HAD)

  • Impairment involves at least two cognitive domains and results in neuropsychological testing at least 2 SD below the appropriate mean age/education norm for:
    • Information processing speed
    • Short-term and long-term memory
    • Ability to learn new skills and solve problems
    • Attention, concentration, and distractibility
    • Logical and abstract reasoning functions
    • Ability to understand and express language
    • Visual-spatial organization Visual-motor coordination
    • Planning, synthesizing and organizing abilities Cognitive impairment significantly interferes with work, home life, social activities or ADL's.
    • Non-HIV healthy Controls Our P300 COGNISION apparatus, provided by Neuronetrix, has been used only in subjects over the age of 60, whereas our participants in the HAND study will all be younger than 60. So, we cannot use COGNISION normative data base for comparison. We will add 10 HIV- healthy controls to our planned 40 HIV+ subjects. These HIV- participants will be age- and gender-matched to the HIV- Asymptomatic Neurocognitive Impairment (ANI) patients, and will undergo all the same assessments

    Our IRB-approved study of HAND is limited to neuropsychological assessment. The study could be improved by adding a biological marker assessment, which could help validate the HAND categories. Such a marker is the P300 event-related potential (ERP), known to be related to cognitive processes, such as attention and working memory and abnormal in most neurologic and mental disorders. It could also possibly detect vulnerability to later cognitive impairment in those determined to be of normal cognition by neuropsychological testing. For example, Olichney et al (2011) concluded that ERP studies of individuals at risk for AD may reveal neurophysiological changes prior to clinical deficits, which could advance the early detection and diagnosis of "pre-symptomatic AD". Another example of the association of the P300 and cognition was the study of Onofri et al (2003). In this study donepezil resulted in improved cognition, as measured by a significant increase in MMSE scores. This was accompanied by a reduction of P3 latency. Logistic analysis showed that P3 latency predicted the beneficial effect of donepezil.

    Eligibility

    Eligibility

    Ages Eligible for Study: 25 Years to 75 Years  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: Yes  
    Sampling Method: Probability Sample  

    Study Population

    HIV+ individuals and Healthy controls (HIV-, age and gender matched)

    Criteria

    Inclusion Criteria:

    • All participants will have been diagnosed as HIV+.
    • Health controls with be age (+/- 5 years) and gender matched to the HIV+ participants.


    Exclusion Criteria:
    • Alzheimer's DIsease
    • Vascular Dementia
    • Delirium
    • Severe Depression
    • CNS Neoplasm
    • CNS Infection Other Than HIV/AIDS
    • Cerebrovascular Disease
    • Alcohol Or Drug Intoxication Or Dependence
    • Parkinson's
    • Thyroid Disease
    • Pernicious Anemia
    • Subdural Hematoma
    • Occult Hydrocephalus
    • Huntington's
    • Creutzfeldt-Jakob
    • Electroconvulsive Therapy
    • Seizure Disorder
    • Medical/Psychiatric Disease
    • Medication Influencing Cognition

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02187796

    Locations

    United States, Tennessee
    Quillen College of Medicine at East Tennessee State University
    Johnson City, Tennessee, United States, 37614

    Sponsors and Collaborators

    East Tennessee State University
    Neuronetrix, Inc.

    Investigators

    Principal Investigator: Norman C Moore, MD Psychiatry and Behavioral Sciences, Quillen College of Medicine, East Tennessee State University
    Study Chair: Jonathan P Moorman, MD,Ph.D,FACP Infectious Diseases, Internal Medicine, Quillen College of Medicine, East Tennessee State University
    More Information

    More Information


    Responsible Party: Dr. Norman Moore, Director of Research, Department of Psychiatry, East Tennessee State University  
    ClinicalTrials.gov Identifier: NCT02187796   History of Changes  
    Other Study ID Numbers: 0214.24s  
    Study First Received: July 9, 2014  
    Last Updated: August 3, 2015  

    Keywords provided by Dr. Norman Moore, East Tennessee State University:

    HIV
    Dementia
    HAND
    COGNISION System
    ERP
    event-related potentials

    Additional relevant MeSH terms:
    Disease
    Neurocognitive Disorders

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.