NCT06112639 · RECRUITING
The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
This trial tests DANCEREX-DTx, a digital app that guides people through dance and music-based exercise sessions designed for brain and neurological health. Participants are randomly assigned to the full app experience, dance-only sessions, or an educational program. Researchers want to know whether the digital motivational layer improves how consistently people stick with the program. This is a proof-of-concept study, meaning it is an early-stage test of feasibility and initial effectiveness, not a proven treatment.
You may qualify if
- age between 18 and 85 years (adult and older adult);
- education equal to or more than five years
- agreement to participate with the signature of the informed consent form;
- 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
- Normal score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test > 15.5 Santangelo et al., 2015)
You're excluded if
- 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)
- presence of overt hearing/visual impairment
- for the MCI group, the absence of a caregiver/study partner able to support the participant;
- no living in one's own home;
- for the MS group, score in cerebellum function at EDSS greater than 3
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-10