Impact of Telerehabilitation on Brain Connectivity in Mild Cognitive Impairment

Neural and Clinical Correlates of Rehabilitation in Neurodegenerative Conditions

This study is trying out new online brain training programs for people with Mild Cognitive Impairment to see if they can help improve brain function and quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: University of Pavia (Academic / other)
• Locations: 1 site (Pavia)
• Trial ID: NCT06278818 on ClinicalTrials.gov

What this trial studies

This project assesses the effects of cognitive telerehabilitation approaches on patients with Mild Cognitive Impairment (MCI) related to neurodegenerative diseases like Alzheimer's and Parkinson's. It employs innovative non-pharmacological interventions to help maintain functionality, slow disease progression, and enhance the quality of life for patients and caregivers. The study utilizes high-density electroencephalogram (HD-EEG) and resting-state functional magnetic resonance imaging (rsFMRI) to evaluate the impact of these interventions on brain network connectivity. By identifying neurophysiological correlates, the study aims to improve cognitive performance in individuals with MCI.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Mild Cognitive Impairment due to Alzheimer's or Parkinson's disease who can understand and consent to study procedures.

Not a fit: Patients with advanced dementia or significant sensory disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance cognitive function and quality of life for patients with Mild Cognitive Impairment.

How similar studies have performed: While the effectiveness of non-pharmacological interventions in cognitive decline is still debated, there is growing interest and some preliminary success in similar approaches.

Eligibility criteria

Inclusion criteria for MCI-AD subjects:

* Confirmed clinical diagnosis of MCI due to possible Alzheimer\'s disease with evidence of AD pathophysiological processes, according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association criteria (Albert et al., 2011);
* Ability to understand and consciously sign informed consent and adhere to study procedures.
* Educational level ≥ 5 years.

Inclusion criteria for MCI-PD subjects:

* Clinical diagnosis of MCI-PD according to Level II criteria (Litvan et al., 2012). Ability to understand and consciously sign informed consent and adhere to study procedures.
* Educational level ≥ 5 years.

Exclusion criteria:

* Aphasia, visuospatial neglect;
* Atypical and/or secondary parkinsonisms;
* Dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria;
* Alterations of consciousness;
* Sensory disorders that could interfere with the execution of tests and rehabilitative treatment;
* Concurrent psychiatric and/or neurological and/or essential tremor disorders;
* Presence of systemic inflammatory and infectious diseases, autoimmune diseases, malignant tumors at the time of recruitment, deemed clinically significant by the investigator and therefore capable of interfering with the study results;
* Inability or unwillingness to undergo MRI and/or EEG;
* Presence of prostheses or metallic implants incompatible with MRI;
* Deep brain stimulation (DBS) implant.
* Any dropouts will be managed by enrolling new patients.

Where this trial is running

Pavia

• IRCCS Mondino Foundation — Pavia, Italy (Recruiting)

Study contacts

• Principal investigator: Cristina Tassorelli, MD — University of Pavia
• Study coordinator: Cristina Tassorelli, MD

Conditions Mild Cognitive Impairment; Non-pharmacological treatments; Cognitive training; Rehabilitation; Dementia; Connectivity; Neuroimaging