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

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ClinicalTrials.gov Identifier: NCT02187796
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : August 4, 2015
Sponsor:
Collaborator:
Neuronetrix, Inc.
Information provided by (Responsible Party):
Dr. Norman Moore, East Tennessee State University

Brief Summary:
  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 )
  2. To determine whether the following variables affect the three categories of HAND

    • Time since first diagnosis of HIV infection
    • Anti-viral medications used
    • Age
    • Gender

Condition or disease
HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 50 participants
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
Study Start Date : May 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
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



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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 :
  1. 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.

  2. 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).



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
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

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): NCT02187796


Locations
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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
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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
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Responsible Party: Dr. Norman Moore, Director of Research, Department of Psychiatry, East Tennessee State University
ClinicalTrials.gov Identifier: NCT02187796    
Other Study ID Numbers: 0214.24s
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015
Keywords provided by Dr. Norman Moore, East Tennessee State University:
HIV
Dementia
HAND
COGNISION System
ERP
event-related potentials
Additional relevant MeSH terms:
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Neurocognitive Disorders
Mental Disorders