Clinical trial NCT06112639: The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
Official title: DANCE REhabilitation Experience (DANCEREX-DTx): Protocol for a Randomized Controlled Trial on Effectiveness of Digital Therapeutics in Chronic Neurological Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sclerosis, Multiple
Neurocognitive Impairment, Mild
Neurocognitive Dysfunction
Keywords: rehabilitation
multiple sclerosis
dementia
digital therapeutics
neurocognitive dysfunction
MRI
neuroinflammation
telerehabilitation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: IRCCS Centro San Giovanni di Dio Fatebenefratelli
name: University of Milano Bicocca
name: IRCCS Centro Neurolesi Bonino Pulejo
First posted: 2023-11-01
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test a new digital therapeutic solution which combines a holistic, multidimensional rehabilitation program based on dance and music with an innovative motivational system (DANCEREX-DTx) in Chronic Neurological Disorders (Multiple Sclerosis and pre-Mild Cognitive Impairment - MCI/ MCI at risk of Alzheimer's Disease). The main questions it aims to answer are 1\] efficacy of the digital therapeutic solution in terms of adherence, clinical/functional measures, quality of life and surrogate measures; 2\] usability and acceptability of the system.

Participants will be randomized (with an allocation ratio of 2:2:1) into the experimental group (DANCEREX - 24 sessions of multidimensional dance-based program integrated with an innovative motivational system), active comparator group (24 sessions of multidimensional dance-based program) and placebo group (24 sessions of educational program). Researchers will compare the experimental group to the other two groups to see if a digital therapeutic solution integrating a multidimensional dance-based program and motivational system is effective in increasing adherence to rehabilitation treatment.


Eligibility criteria: Inclusion Criteria:

1. age between 18 and 85 years (adult and older adult);
2. education equal to or more than five years
3. agreement to participate with the signature of the informed consent form;
4. clinical diagnosis of Multiple Sclerosis (MS) according to the 2017 revised criteria of MC Donald - Expanded Disability Status Scale (EDSS) score equal or less than 4.5, R-R disease course, freedom from relapses, and steroid treatment for at least one month, OR clinical diagnosis of pre-Mild Cognitive Impairment - MCI (Subjective Memory Complaints and/or Subjective Cognitive Complaints)/MCI at risk of Alzheimer's Disease with the Clinical Dementia Rating (CDR) scale equal or less than 0.5
5. Normal score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test \> 15.5 Santangelo et al., 2015)

Exclusion Criteria:

1. presence of comorbidities that prevent patients from undertaking a safe home program (e.g., balance problems, history of falls in the past 6 months, use of assistive devices for deambulation)
2. presence of overt hearing/visual impairment
3. for the MCI group, the absence of a caregiver/study partner able to support the participant;
4. no living in one's own home;
5. for the MS group, score in cerebellum function at EDSS greater than 3

Primary outcomes:
measure: Adherence to treatment
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Conti et al., 2015)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Change in visuoperceptual and attentional abilities measured by Symbol Digit Modalities Test (SDMT; Smith A., 1973; Nocentini U., 2006)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Change in executive functions, including visual attention and inhibitory control of behavior measured by Stroop Test (Caffarra et al., 2002)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Change in Verbal and semantic fluency measured by The Verbal Fluency and Semantic Tests (Carlesimo et al., 1996; Novelli et al., 1986).
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Change in long term visual memory measured by Free and Cued Selective Reminding Test (FCSRT) (Frasson et al., 2011)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Change in long term verbal memory measured by 15-Words of Rey (Carlesimo et al., 1995)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Change in Static and dynamic balance measured by Mini-Best Test (Franchignoni et al., 2010)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Change in Aerobic Capacity and Gait measured by 6' Minute Walking Test (6MWT)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Changes in affect measured by Positive-Negative Affect Schedule (PANAS; Watson et al, 1988)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Changes in patient's self-rated health measured by EuroQol five dimensions (5D) and five levels (5L) (The EuroQol Group, 1990; Janssen et al.,2013)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Changes in patient's self-rated health status measured by Short Form Health Survey 36 (SF36; Ware, 2000)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Changes in patient's fatigue measured by Modified Fatigue Index Scale (MFIS; Kos et al., 2006)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Changes in depressive symptoms measured by Beck Depression Inventory for Primary Care (BDI-PC, Steer et al., 1999)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
measure: Changes in anxiety level measured by State-Trait Anxiety Inventory - Form Y (STAI - Y; Spielberger, 1983; Pedrabissi & Santinello, 1989)
timeFrame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Other outcomes:
measure: Changes in brain morphometry as detected by Magnetic Resonance Imaging Examination.
timeFrame: Time Frame: Baseline, post-treatment (up to 12 weeks)
measure: Changes in structural connectivity as detected by Magnetic Resonance Imaging Examination.
timeFrame: Time Frame: Baseline, post-treatment (up to 12 weeks)
measure: Changes in functional connectivity as detected by Magnetic Resonance Imaging Examination.
timeFrame: Time Frame: Baseline, post-treatment (up to 12 weeks)
measure: Changes in inflammatory and anti-inflammatory cytokines as measured by blood sampling
timeFrame: Time Frame: Baseline, post-treatment (up to 12 weeks)
measure: Changes in protein associated to downstream inflammasome activation as measured by blood sampling
timeFrame: Time Frame: Baseline, post-treatment (up to 12 weeks)
measure: Changes in neurotrophic and neuroendocrine factors as measured by blood sampling
timeFrame: Time Frame: Baseline, post-treatment (up to 12 weeks)
measure: Changes in neurodegenerative marker as measured by blood sampling
timeFrame: Time Frame: Baseline, post-treatment (up to 12 weeks)
Locations:
city: Brescia
country: Italy
facility: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino-Pulejo
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi ONLUS
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi ONLUS
name: Maria Pia Amato
role: PRINCIPAL_INVESTIGATOR
References: