Digital therapeutic program combining dance and music for chronic neurological disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy of a new digital therapeutic solution called DANCEREX-DTx, which integrates a multidimensional rehabilitation program based on dance and music with a motivational system. Participants will be randomized into three groups: one receiving the DANCEREX program, another receiving a dance-based program without the motivational component, and a placebo group receiving an educational program. The study will assess adherence, clinical and functional measures, quality of life, and the usability and acceptability of the system among individuals with Multiple Sclerosis and pre-Mild Cognitive Impairment. The trial seeks to provide insights into the potential benefits of dance-based rehabilitation in improving cognitive and functional outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
  Brescia, Italy Recruiting
• IRCCS Centro Neurolesi Bonino-Pulejo
  Messina, Italy Recruiting
• IRCCS Fondazione Don Carlo Gnocchi ONLUS
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Maria Pia Amato — IRCCS Fondazione Don Carlo Gnocchi ONLUS
• Study coordinator: Francesca Baglio, MD
• Email: fbaglio@dongnocchi.it
• Phone: +390240308952

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving attention in military personnel with mild traumatic brain injury using brain stimulation and cognitive training

  This study is testing a new way to help Active Duty Service Members and Veterans with mild traumatic brain injury improve their attention by combining brain stimulation with cognitive training.

  Recruiting at 2 sites United States Naval Medical Center, San Diego · San Diego, California and 1 other locations · NCT06413173

• Using memantine to protect memory and cognition during craniospinal irradiation

  This study is testing if the drug memantine can help protect memory and thinking skills in patients getting radiation treatment for brain tumors.

  Recruiting Phase 3 Tata Memorial Centre · Mumbai, Maharashtra · NCT06275035

• Finding early biological signs of severe illness in ICU patients

  The study will collect blood, lung, and rectal samples from adults newly admitted to the ICU to see if early biological signs can help diagnose and personalize care for sepsis, ARDS, or other critical illnesses.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT05591924

• Butyrate treatment for Gulf War Illness

  This study is testing if a butyrate treatment can help improve physical function and reduce symptoms in Veterans with Gulf War Illness.

  Recruiting at 3 sites Phase 2 VA Office of Research and Development · Long Beach, California and 2 other locations · NCT05367245

• Using a passive home sensor to find digital signs of brain energy changes from nicotinamide riboside

  This project will try a contact-free home sensor to see if it can detect activity, sleep, and breathing changes related to nicotinamide riboside in people with mild cognitive impairment or mild Alzheimer's.

  Recruiting Mclean Hospital · Belmont, Massachusetts · NCT05245903

• Hyperbaric oxygen for long COVID cognitive and fatigue symptoms

  This trial will try hyperbaric oxygen therapy versus a sham treatment to see if it helps adults with long COVID who still have thinking problems, memory issues, fatigue, or other lingering symptoms at least three months after infection.

  Recruiting Assaf-Harofeh Medical Center · Tsrifin · NCT04647656

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.