Digital solutions for early treatment of cognitive disabilities in chronic neurological diseases
EARLY-COGN^3 - Smart Digital Solutions for EARLY Treatment of COGnitive Disability: a Neuropsychological, Neurophysiological and Neurobiological Perspective in Chronic Neurological Diseases - PNRR-MCNT2-2023-12377069
This study is testing a digital brain training program to see if it helps people with Mild Cognitive Impairment, subjective cognitive complaints, or Parkinson's Disease improve their thinking skills compared to a different type of brain activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 3 sites (Brescia, IT and 2 other locations) |
| Trial ID | NCT06657274 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 85 with a diagnosis of MCI, SCCs, or PD who meet specific cognitive assessment criteria.
Not a fit: Patients with significant psychiatric or medical conditions that could interfere with assessments or those currently undergoing rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cognitive function and quality of life for patients with early-stage cognitive impairments.
How similar studies have performed: Previous studies have shown promise in using digital cognitive interventions for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brescia, IT and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.