NCT06112639 The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
| NCT ID | NCT06112639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi ETS |
| Condition | Sclerosis, Multiple |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2024-01-31 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Maria Pia Amato
PRINCIPAL INVESTIGATOR
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Frequently Asked Questions
Who can join the NCT06112639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Sclerosis, Multiple. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06112639 currently recruiting?
Yes, NCT06112639 is actively recruiting participants. Contact the research team at fbaglio@dongnocchi.it for enrollment information.
Where is the NCT06112639 trial being conducted?
This trial is being conducted at Brescia, Italy, Messina, Italy, Milan, Italy.
Who is sponsoring the NCT06112639 clinical trial?
NCT06112639 is sponsored by Fondazione Don Carlo Gnocchi ETS. The principal investigator is Maria Pia Amato at IRCCS Fondazione Don Carlo Gnocchi ONLUS. The trial plans to enroll 192 participants.