Computerized Cognitive Rehabilitation of Patients With Cognitive Deficits Due to the Human Immuno… (NCT06603727) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Computerized Cognitive Rehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus
Switzerland24 participantsStarted 2024-10-01
Plain-language 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 cause deficits in cognitive function, even under effective pharmacological viral load suppression. Cognitive dysfunction in patients with HIV is frequent and has a detrimental impact on their everyday personal and professional life. The purpose of this study is to evaluate two sets of computerized exercises combining cognitive and physical effort to see if they can improve executive function in patients with an HIV infection.
WHAT: Study participants first undergo cognitive and physical assessments. Additional questionnaires will assess mood, everyday life cognition, function and quality. This will be followed by a 6 week training period with 2 training sessions a week. The effect of the physical and cognitive training will be measured in a post-training evaluation session. Six months after completion of the training, the study will evaluate cognitive and physical abilities of participants to study long-term effects of the respective training program.
WHERE: Both the evaluation and the training sessions will be conducted on the premises of the Lausanne University Hospital (Rue du Bugnon 46, 1005 Lausanne, Switzerland)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in subjective everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Timeframe: 6 weeks
2
Change in speed of information processing after a 6 weeks period of gamified cognitive and physical training
Timeframe: 6 weeks
3
Change in cognitive flexibility after a 6 weeks period of cognitive and physical training (program 1 vs program 2)
Timeframe: 6 weeks
4
Change in visuospatial short-term memory after a 6 weeks period of cognitive and physical training (program 1 vs program 2)