Tests a home-based digital cognitive training program for thinking problems

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Parkinson's disease, mild cognitive impairment or subjective cognitive complaints who can do cognitive exercises at home with a caregiver's support.

Age

18 to 85 years

Sex

All sexes can join.

Disease stage

Parkinson's disease with Hoehn & Yahr below 3; mild cognitive impairment with CDR 0.5 or lower and MMSE 24 or higher; or subjective cognitive complaints. MoCA corrected score 17.36 or higher.

Earlier treatment

No rehabilitation program at enrolment or in the last 3 months. Drug treatment, if any, stable for the last 3 months.

Main reasons for not taking part

• Any medical or psychiatric illness that could interfere with completing the assessments
• Any medical condition that is a contraindication to TMS
• Marked hearing or visual impairment
• Fewer than 5 years of education
• Not a native Italian speaker

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 85 years old?YesNo

What the trial wants to find out

The increase in life expectancy in recent decades has led to a large number of people living into old age and an increased risk of developing Chronic Neurological Diseases (CNDs) such as neurodegenerative diseases. A higher cumulative risk of dementia has been largely demonstrated in Mild Cognitive Impairment (MCI) and Subjective Cognitive Complaints (SCCs) subjects and in Parkinson's Disease (PD) patients, as compared to the general population. These disorders result in an impairment of the individual's abilities to perform daily tasks. As their disease progresses, patients become dependent on medical services and on family support. Given the limited effectiveness of pharmacological treatments, non-pharmacological interventions to prevent and treat cognitive deficits and the associated difficulties with activities of daily living in neurodegenerative disease patients have gained attention in recent years and, among these, cognitive training offers a potential approach for dementia prevention and improvement of cognitive function. A critical aspect of cognitive training programs is that the most promising interventions have involved intensive in-person sessions that are unlikely to be cost-effective or feasible for large-scale implementation. Within the framework of non-pharmacological interventions, the use of technology to assist the person at risk and/or with mild dementia at home and to extend rehabilitation services in the treatment of dementia has gradually gained importance. Telerehabilitation technologies allow to provide services remotely in patients' homes, allowing access to health care to patients living in rural settings or with mobility difficulties. In addition, the telerehabilitation modality offers the advantage of providing rehabilitation within the natural environment of the patient's home, making the treatment more realistic and possibly more generalizable to the person's daily life. The present project proposes to test a home-based asynchronous cognitive telerehabilitation program aimed at enhancing the continuum of care for MCI, SCCs and PD, using technology. The proposed study is a single blind randomized controlled trial (RCT) involving subjects with CNDs randomly assigned to one out of two intervention groups: i) the tele@cognitive group, who will receive at-home cognitive telerehabilitation (tele@cognitive treatment); ii) the Active Control Group (ACG), who will receive at-home unstructured cognitive stimulation. The aim of the project will be threefold: [1] to test the short-term and long-term efficacy of tele@cognitive protocol as compared to an unstructured cognitive at-home rehabilitation in the treatment of a cohort of patients with CNDs; [2] to explore the changes induced by tele@cognitive intervention on biomolecular and neurophysiological markers; [3] to explore potential cognitive, neurobiological and neurophysiological predictors of response to tele@cognitive treatment.

The 2 groups in the trial

• tele@cognitive treatmentTreatment being tested

  The tele@cognitive treatment group will receive a total of 5 weeks (3 sessions/week, 45 minutes/session) of home-based cognitive rehabilitation activities delivered through a digital telerehabilitation platform.

  Treatment: RICORDO-DTx

• Active Control Group (ACG)Existing treatment, for comparison

  The Active Control Group (ACG), will receive at-home unstructured cognitive stimulation for 5 weeks (3 sessions/week, 45 minutes/session).

  Treatment: Home-based unstructured cognitive stimulation