Computerized Cognitive Rehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Vaudois

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Color Trail Test (CTT) Flexibility Index

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Computerized Gaming Rehabilitation Program 1

    Device

    Brain training games displayed on a large screen paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching in place.

  • Computerized Gaming Rehabilitation Program 2

    Device

    Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Program 1Experimental treatment 1 intervention
Group B: Program 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in subjective everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

Subjective executive function is measured by the Working Memory Questionnaire (WMQ), a 30-item, self-administered scale (score range from 0 to 120), addressing working memory (10 items), attention (10 items) and general executive function (10 items). The higher the score, the more it reflects cognitive difficulties.

Time frame
6 weeks
2

Change in speed of information processing after a 6 weeks period of gamified cognitive and physical training

Measured by the Symbol Digit Modalities Test (SDMT), scored from 0 to 110. The lower the score, the more it reflects cognitive difficulties.

Time frame
6 weeks
3

Change in cognitive flexibility after a 6 weeks period of cognitive and physical training (program 1 vs program 2)

Measured by the time completion of the Color Trails Test (CTT) in CTT1 and CTT2 (i.e., Flexibility Index: (CTT2-CTT1)/CTT1). The higher the Flexibility Index, the more it reflects cognitive difficulties.

Time frame
6 weeks
4

Change in visuospatial short-term memory after a 6 weeks period of cognitive and physical training (program 1 vs program 2)

Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R), scored from 0 to 36. The lower the score, the more it reflects cognitive difficulties.

Time frame
6 weeks

Secondary outcomes

1

Change in sustained attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

Measured with the Test of Variables of Attention (TOVA) using the reaction time (RT) and the false alarm rate (FA). The higher the RT and FA, the more they reflect cognitive difficulties.

Time frame
6 weeks
2

Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

Measured with the Denis-Kaplan Color-Word interference Stroop test using the time completion in each condition. The higher the time completion, the more it reflects cognitive difficulties.

Time frame
6 weeks
3

Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

The Five-Point Test will be used to assess design fluency using the total number of design produced. The lower the score, the more it reflects cognitive difficulties.

Time frame
6 weeks
4

Change in cognitive flexibility after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

A subtest of a custom-made tablet-based cognitive evaluation tool will measure cognitive flexibility.

Time frame
6 weeks

Other outcomes

1

Subjective usability of the technology used in study.

Regardless of training group attribution, study participants will rate the user-friendliness of the training using the 10-item System Usability Scale scored from 0 to 40. The higher the score, the better the utility.

Time frame
6 weeks
2

Subjective experience with technology used in the study

Regardless of training group attribution, study participants will rate the experience of the training using and the 4-item Perception of game training questionnaire scored from 10 to 50. The higher the score, the better the experience.

Time frame
6 weeks
3

Perception of game training

Regardless of training group attribution, study participants will rate their perception of game training using the Perception of game training questionnaire (4 statements on enjoyment, challenge, frustration and motivation associated with the game, participants rate their agreement with the statement on a Likert-scale from 1 (lowest) to 7 (highest)).

Time frame
6 weeks

Sponsors and contacts

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