Status:
NOT_YET_RECRUITING
Computerized Cognitive Rehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Human Immunodeficiency Virus
Cognitive Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
WHO: 24 participants with cognitive deficits due to a Human Immunodeficiency Virus (HIV) infection, able to engage in moderate physical activity. WHY: The Human Immunodeficiency Virus is known to cau...
Detailed Description
This is an exploratory Randomized Controlled Trial with the purpose of evaluating the potential of two sets of gamified cognitive and physical exercises in the neurorehabilitation of cognitive deficit...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Diagnosis of an HIV infection
- Undetectable HIV load in the serum (\<50 copies/mL) over the last 6 months prior to study inclusion.
- Z-score ≤ -1.0 in at least one of the three following tests:
- Color Trail Test (CTT) Flexibility Index
- subtest Code of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
- subtest Digit Span of the WAIS-IV
- Z-score ≤ -1.0 in at least one of the following tests:
- Symbol Digits Modalities Test (SDMT)
- Brief Visuospatial Memory Test Revised (BVMT-R)
- CTT Flexibility Index
- Stroop Color-Word interference test
Exclusion
- Clinically defined cause for cognitive deficits other than HIV
- Diagnosis of severe depression according to a cut-off score of ≥ 27 of the Center for epidemiological studies - depression questionnaire (CES-D; Metral et al., 2020; Radloff, 1977)
- Diagnosis of HIV-associated dementia according to the Frascati Critera (Antinori et al., 2007)
- Current psychotic symptoms according to the Mini-International Neuropsychiatric Interview (M.I.N.I. - L, Sheehan et al., 1998) subscale of psychotic symptoms
- Antidepressive, anxiolytic or cART medication that has been changed over the last month
- Thoracic pain and/or heart palpitations at rest, during or following a physical effort (based on self-report)
- For patients without known and clinically stable cardio-vascular disease: abnormal rest electrocardiogram readings suggestive of second degree type Mobitz or third degree atrioventricular blocking, pathological repolarization (T-wave inversion, ST elevation, abnormal QT lengthening in at least two corresponding leads), or typical features of channelopathies
- Premature termination of maximal effort test due to cardiac problems
- Falls in the past 12 weeks as evaluated in the enrolment interview (Hopkins Falls Grading Scale, Grade \>1)
- High risk of falling according a cutoff score \> 15 sec in the Four Square Step Test (Dite \& Temple, 2002)
- Incapacity to discriminate colors or insufficient visual acuity that cannot be corrected
- Incapacity or unwillingness to provide informed consent
- Insufficient knowledge of French to understand and follow instructions
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06603727
Start Date
October 1 2024
End Date
August 31 2026
Last Update
September 19 2024
Active Locations (1)
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1
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011