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

NCT06603727 | Not Yet Recruiting DMC

• 1 other identifier: CHUV-DNC-CCT-HIV-2022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Human Immunodeficiency Virus; Cognitive Dysfunction

Keywords

HIV Infections; Communicable Diseases; Neurological Rehabilitation; Cognitive Behavioural Therapy; Exercise Therapy; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Mental Disorders

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (30)

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

  6 weeks

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

  6 weeks

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

  6 weeks

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

  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)

  6 weeks

Other Outcomes (3)

• Subjective usability of the technology used in study.

  6 weeks

• Subjective experience with technology used in the study

  6 weeks

• Perception of game training

  6 weeks

Study Arms (2)

Program 1

EXPERIMENTAL

Computerized Gaming Rehabilitation Program 1

Device: Computerized Gaming Rehabilitation Program 1

Program 2

ACTIVE COMPARATOR

Computerized Gaming Rehabilitation Program 2

Device: Computerized Gaming Rehabilitation Program 2

Interventions

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.

Program 1

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.

Program 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of an HIV infection
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Lausanne University Hospital (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cognitive Dysfunction; HIV Infections; Communicable Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arseny A. Sokolov, Prof MD PhD

  Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

• Etienne Sallard, PhD

  Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

  STUDY CHAIR

Central Study Contacts

Etienne Sallard, PhD

CONTACT

+ 41 21 314 24 61; etienne.sallard@chuv.ch

Arseny A. Sokolov, Prof MD PhD

CONTACT

+41 79 556 73 55; arseny.sokolov@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will affect participants and study personnel, with exception to the personnel supervising the training programs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)