HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND) Clinical Trial
— HANDOfficial title:
PREVALENCE of HIV-ASSOCIATED NEUROCOGNITIVE DISORDERS (HAND) in a SCHOOL of MEDICINE HIV/AIDS OUTPATIENT CLINIC
Verified date | August 2015 |
Source | East Tennessee State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 25 Years to 75 Years |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Quillen College of Medicine at East Tennessee State University | Johnson City | Tennessee |
Lead Sponsor | Collaborator |
---|---|
East Tennessee State University | Neuronetrix, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IntegNeuro | 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 |
at enrollment | No |
Primary | IADL (Instrumental Activities of Daily Living Scale) | 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. | at enrollment | No |
Primary | Medical Outcomes Study HIV (MOS-HIV) Health Survey | 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. | at enrollment | No |
Secondary | MMSE (Mini Mental State Exam) | The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. | at enrollment | No |
Secondary | COGNISION P300 ODD- BALL DEVICE | 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). | at enrollment | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02989285 -
Identification and Quantification of HIV CNS Latency Biomarkers
|