Home-based EXergames To impRove cognitivE Function in MUltiple Sclerosis (EXTREMUS)

San Camillo Hospital, Rome

Status

Unknown

Conditions

Multiple Sclerosis

Treatments

Behavioral: Sham COGNI-TRAcK

Behavioral: Adaptive COGNI-TRAcK

Behavioral: Exergames

Study type

Interventional

Funder types

Other

Identifiers

NCT04169750

2017/R/22

Details and patient eligibility

About

Study design: Phase II, multicenter, randomized, sham-controlled, single-blind, parallel arm, multicenter study to test the hypothesis that home-based exergames is not inferior to home-based cognitive rehabilitation delivered by a software application (app) for mobile devices and both interventions are superior to a placebo-analogue cognitive intervention in improving cognitive function and reducing cognitive-motor interference in people with multiple sclerosis (MS).

Procedures: Participants will be randomized in a 1:1:1 ratio to receive an 8-week home-based training with exergames (intervention of interest) or adaptive COGNI-TRAcK (comparator intervention) or sham COGNI-TRAcK (placebo-analogue intervention). Study assessment will be done at study enrolment (baseline), at the end of the 8-week intervention period (immediate post-training, Week 8) and after 16 weeks from randomization (post-training follow-up, Week 16).

Investigational interventions:

Exergames: home-based repetition of several games delivered by the Nintendo © Wii Balance Board, a commercial off-the-shelf video game console for re-training of balance and postural strategies
Adaptive COGNI-TRAcK: adaptive (i.e. automatic adjustment of tasks difficulty) working memory training delivered by a customized application software for mobile devices to self-administer at-home
Sham COGNI-TRAcK: non-adaptive (i.e. constant difficulty level) working memory training delivered by the same app as afore described

Primary endpoint: changes at the Symbol Digit Modalities Test (SDMT), a measure of sustained attention and information processing speed.

Secondary endpoint: changes at the BICAMS (z-scores), a brief, practical and universal assessment tool for cognitive impairment in MS.

Additional endpoints: magnitude of cognitive-motor interference estimated as dual-task cost of balance and walking.

Sample size estimation: The investigators estimated a pre-defined 8-point non-inferiority margin, based on a significant effect of the COGNI-TRAcK in inducing an about 8-point mean increase at SDMT score (with respect to a sham intervention). Accordingly, 35 participants per arm are required to ensure, with an approximately 85%-power level, that the lower limit of a one-side 95% confidence interval will be above the pre-defined non-inferiority margin. Therefore, considering also a drop-out rate of 25%, a total of 132 subjects should be enrolled.

Enrollment

135 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age between 18 and 55 years (inclusive);
cognitive impairment, defined as failure in the SDMT, defined as a corrected score less than 38, i.e. below the 5th percentile of normative value;
Expanded Disability Status Scale (EDSS) score between 2.0 and 5.5;
ability to stand upright for at least 180 seconds without any support;
ability to understand and comply with study requirements;
ability to provide a valid informed consent before any study procedure.

Exclusion criteria

relapse in the previous 6 months;
initiation of disease-modifying or symptomatic treatments or physiotherapy programme in the 3 months prior to study entry;
any medication/physiotherapy changes occurring over the previous 3 months;
significant visual impairment, defined as a Visual System scoring more than 2 at the Kurtzke Functional Systems Score;
clinically relevant depression, defined as Beck Depression Inventory-II (BDI-II) score equal or more than 14;
overt dementia, defined as an adjusted Mini Mental State Examination (MMSE) score equal or less than 24;
history of epilepsy or seizures;
any medical condition, including musculoskeletal disorders that can interfere with the study conduction.