Pilot Study on Combined Cognitive and Physical Training for Neurorehabilitation of Cognitive Deficits Related to HIV

ICTRP Trial ID
NCT06603727 (ICTRP)

Official title (approved by ethics committee)
Combined Cognitive and Physical Training for the Neurorehabilitation of Patients with Cognitive Deficits due to the Human Immunodeficiency Virus: a Pilot Study (BASEC)

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

Public title
Computerized Cognitive Rehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus (ICTRP)

Disease under investigation
Human Immunodeficiency Virus;Cognitive Dysfunction (ICTRP)

Intervention under investigation
Device: Computerized Gaming Rehabilitation Program 1;Device: Computerized Gaming Rehabilitation Program 2 (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)

Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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 testExclusion 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 (ICTRP)

not available

Primary and secondary end points
Change in subjective everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in speed of information processing after a 6 weeks period of gamified cognitive and physical training;Change in cognitive flexibility after a 6 weeks period of cognitive and physical training (program 1 vs program 2);Change in visuospatial short-term memory after a 6 weeks period of cognitive and physical training (program 1 vs program 2) (ICTRP)

Change in sustained attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in cognitive flexibility after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);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);Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);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);Change in risk of falls after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in limits of postural stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);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);Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in systolic and diastolic blood pressure after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in anxiety after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in everyday life activity / quality of life after a 6 weeks period of gamified cognitive and physical training;Change in everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in fatigue after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in apathy after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Change in alcohol and other substance consumption after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2);Development of medication intake over the course of study participation.;Development of professional occupation/employment rate over the course of study participation.;Development of self-reported activity profile over the course of study participation.;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);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);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);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);Change in maximal pulmonary capacity (measured in liters) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2);Change in peak oxygen capacity (VO2 peak) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2);Change in VO2 at anaerobic threshold after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Arseny A. Sokolov, Prof MD PhD;Etienne Sallard, PhD;Etienne Sallard, PhD, etienne.sallard@chuv.ch, + 41 21 314 24 61, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland,Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland, (ICTRP)

Secondary trial IDs
CHUV-DNC-CCT-HIV-2022 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06603727 (ICTRP)