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

Combined Cognitive and Physical Training for the Neurorehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus: a Pilot Study

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Dysfunction; Human Immunodeficiency Virus
• Intervention / Treatment: Device: Computerized Gaming Rehabilitation Program 1; Device: Computerized Gaming Rehabilitation Program 2

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 deficits due to an infection with the Human Immunodeficiency Virus (HIV).

Upon recruitment, eligible study participants (see 'Eligibility Criteria') receive a detailed oral and written description about the scientific background, aims and methods of the study. Additional information will be provided about potential benefits and risks associated with study participation, as well as about the voluntary nature of participation throughout the study. The participant's written informed consent is required for study enrollment.

After inclusion in the study, participants are randomized into one of two different training programs with equal chance of attribution and without possibility of choosing:

• Program 1 involves brain training and guided, light physical exercise games on a tablet device. The exercise involves movements such as reaching, stepping, and stretching. Warm-up and cool down sessions are mandated prior to and following the tasks.
• Program 2 involves gamified exercises displayed on a large screen. Participants use whole-body movements to complete the tasks. Tasks involve movements such as reaching, stepping, and jogging in place. These movements are tracked by a motion sensor. Warm-up and cool down sessions are mandated prior to and following the training sessions.

Independently of program attribution, participants engage in a pre-training assessment, a six-week training period, a post-training assessment and a 6-month-follow-up assessment.

Before the start of the training, participants are required to perform several cognitive and physical tests (including cyclo-ergospirometry) and fill out a number of questionnaires on subjective cognitive function, mood and quality of life. Additionally, an electroencephalography (EEG) will be performed to measure brain activity. The exercises, the questionnaires and the EEG serve as a baseline evaluation of cognitive, physical and neurophysiological function.

Following the first assessment, study participants engage in a six-week training period. In both programs, participants engage in two weekly trainings of ninety minutes duration each.

After completion of the training period, study participants engage in a post-training assessment to evaluate the effect of training on cognitive and physical performance. This session incorporates the same tasks and questionnaires as in the pre-training visit. An EEG will be used to characterize the training effects on dynamics of the underlying large-scale neuronal networks. The aim of the post-training assessment is to demonstrate immediate training effect of the two programs.

A final follow-up visit is scheduled 6 months after the completion of the last training session. The cognitive and physical testing together with the questionnaires and the EEG will be repeated to examine the long-term effects of the training programs.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arseny A. Sokolov, Prof MD PhD; Phone Number: +41 79 556 73 55; Email: arseny.sokolov@chuv.ch
• Study Contact Backup: Name: Etienne Sallard, PhD; Phone Number: + 41 21 314 24 61; Email: etienne.sallard@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Lausanne University Hospital (CHUV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Program 1; Computerized Gaming Rehabilitation Program 1	Device: Computerized Gaming Rehabilitation Program 1; 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.
Active Comparator: Program 2; Computerized Gaming Rehabilitation Program 2	Device: Computerized Gaming Rehabilitation Program 2; Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic and diastolic blood pressure after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Determined by the mean of three blood pressure measurements using a sphygmomanometer and a stethoscope.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
Change in visuo-spatial and verbal working memory control after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Measured using the Digit and Visuo-Spatial Span Test	6 weeks
Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Measured using the Test of Attentional Performance subtest Divided Attention	6 weeks
Change in body composition (body fat and muscle mass) after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Body composition will be measured by bioelectrical impedance measure using the percentage of body fat and muscle mass.	6 weeks
Change in risk of falls after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Risk of falls will be assessed using the BTrackS Balance Plate (FDA registered class 1 medical device #3010668481).	6 weeks
Change in limits of postural stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Limits of postural will be assessed using the BTrackS Balance Plate (FDA registered class 1 medical device #3010668481).	6 weeks
Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Dynamic stability will be assessed by the Four Square Step Test, which tests the participant's ability to step over objects forwards, sideways and backwards; the movements of the FSST are comparable to the ones implemented in the training program. The score is based on time taken to complete the test. The higher the score, the more it reflects balance difficulties.	6 weeks
Change in ability to perform a cognitive and physical dual task after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	In order to assess cognitive and motor dual task ability, the study participant will perform the Timed Up and Go Cognitive. The score is based on time taken to complete the test and errors or hesitations. The higher the score, the more it reflects cognitive difficulties.	6 weeks
Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Heart rate and heart rate variability will be recorded at rest in supine position during a 5-minute window using a medical electrocardiogramm (ECG).	6 weeks
Change in anxiety after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI; 20 items) in French, scored from 20 to 80. The higher the score, the higher the level of anxiety.	6 weeks
Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Mood will be assessed using the Center for Epidemiologic Studies - Depression (CES-D; 20 items) in French, scored from 0 to 60. The higher the score, the higher the level of depression.	6 weeks
Change in everyday life activity / quality of life after a 6 weeks period of gamified cognitive and physical training	Specifically developped for patients with an HIV infection, the Medical Outcomes Study HIV Health Survey (MOS-HIV; 35 items) will be used to assess everyday life activities and health-related quality of life. The score ranges from 0 to 100. The lower the score, the poorer the quality of life.	6 weeks
Change in everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Everyday life cognition will be assessed using the Cognitive Failure Questionnaire (CFQ; 32 items). The score ranges from 0 to 128. The higher the score, the more it reflects cognitive difficulties.	6 weeks
Change in fatigue after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Study participants will rate their degree of physical, cognitive and psychosocial fatigue on the Modified Fatigue Impact Scale (MFIS; 21 items). The score ranges from 0 to 84. The higher the score, the greater the level of fatigue.	6 weeks
Change in apathy after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	Using the self-administred Dimensional Apathy Scale (DAS; 24 items), study participants will rate their degree of apathy. The score ranges from 0 to 96. The higher the score, the greater the level of apathy.	6 weeks
Change in alcohol and other substance consumption after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	The habits in the consumption of alcohol and other substances will be evaluated with an adapted version of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; 8 items; Khan et al, 2011).	6 weeks
Development of medication intake over the course of study participation.	Participants' medication intake over the course of the study will be recorded in the register of an ongoing prospective, longitudinal and multicenter study, called the Neurocognitive Assessment in the Metabolic and Aging Cohort study (NAMACO).	6 weeks
Development of professional occupation/employment rate over the course of study participation.	Participants' professional occupation/employment rate over the course of the study will be recorded in the register of an ongoing prospective, longitudinal and multicenter study, called the Neurocognitive Assessment in the Metabolic and Aging Cohort study (NAMACO). The employment rate will be measured in full-time equivalent, ranging from 0 to 100 %. The higher the employment rate, the better.	6 weeks
Development of self-reported activity profile over the course of study participation.	Participants' self-reported activity profile over the course of the study will be recorded in the register of an ongoing prospective, longitudinal and multicenter study, called the Neurocognitive Assessment in the Metabolic and Aging Cohort study (NAMACO).	6 weeks
Change in the theta power frequency band over the frontal brain region (Anguera et al., 2022) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)	Measured with an electroencephalogram (EEG) during the Test of Variable of Attention (TOVA).	6 weeks
Change in the latency of the P3b (Event-Related Potential; Anguera et al., 2013) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)	Measured with an electroencephalogram (EEG) during the TOVA.	6 weeks
Change in the temporal dynamic of the resting brain activity (microstates analysis; Michel and Koenig, 2018; Spring et al, 2017) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)	Measured with an electroencephalogram (EEG) during the resting state	6 weeks
Change in forced expiratory volume in one second (FEV1) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)	Measured by a forced exhalation in the first second of a breath into a spirometer.	6 weeks
Change in maximal pulmonary capacity (measured in liters) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)	Measured by a forced exhalation into a spirometer.	6 weeks
Change in peak oxygen capacity (VO2 peak) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)	Measure using a standardized maximal effort test with incremental exercise on a cycling ergometer with gas exchange analyses.	6 weeks
Change in VO2 at anaerobic threshold after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)	VO2 at anaerobic threshold will be determined using a cyclo-ergospirometry.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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.	6 weeks
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)).	6 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Arseny A. Sokolov, Prof MD PhD, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland; Study Chair: Etienne Sallard, PhD, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Cognitive Behavioural Therapy; HIV Infections; Mental Disorders; Cognition Disorders; Exercise Therapy; Neurocognitive Disorders; Neurological Rehabilitation; Communicable Diseases
• Additional Relevant MeSH Terms: Mental Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Neurocognitive Disorders; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Cognitive Dysfunction; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Cognition Disorders
• Other Study ID Numbers: CHUV-DNC-CCT-HIV-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No