Digital solutions for early treatment of cognitive disabilities in chronic neurological diseases

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 study aims to evaluate the effectiveness of a digital cognitive rehabilitation program for patients with Mild Cognitive Impairment (MCI), Subjective Cognitive Complaints (SCCs), and Parkinson's Disease (PD). A total of 60 participants will be recruited and divided into two groups: one receiving home-based cognitive telerehabilitation and the other receiving unstructured cognitive stimulation. Participants will undergo a series of assessments by neuropsychologists and will also have blood samples taken and Transcranial Magnetic Stimulation (TMS) applied at the beginning and end of the treatment. The study will assess cognitive improvements over a 5-week period and at a 3-month follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of PD (Hoehn \& Yahr\<3); MCI (with CDR scale≤0.5, MMSE ≥24), and SCC (Subjective Cognitive Complaints);
* Montreal Cognitive Assessment (MoCA) corrected score ≥17.36
* Education ≥ 5 years
* Age eligible for the study: 18≤age≤85
* Native Italian speakers
* Absence of marked hearing/visual impairment
* All of the subjects will have normal or corrected-to-normal vision.
* Agreement to participate by signing the informed consent form
* Availability of a caregiver/study partner able to support the participant
* No rehabilitation program in place at the time of enrolment or in the last 3 months before enrolment
* Stable drug treatment (last 3 months), if any

Exclusion Criteria:

* Presence of any medical or psychiatric illness that could interfere with completing assessments;
* Presence of any medical condition representing a contraindication to TMS.

Where it's running

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

Study contacts

• Study coordinator: Maria Cotelli, PhD
• Email: mcotelli@fatebenefratelli.eu
• Phone: +390303501457

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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.