Neural and Clinical Correlates of Rehabilitation in Neurodegenerative Conditions

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The current project aims at assessing the impact of various cognitive telerehabilitation approaches on patients with Mild Cognitive Impairment (MCI) associated with neurodegenerative diseases, namely Alzheimer's disease (AD) and Parkinson's disease (PD). The study focuses on non-pharmacological interventions to maintain patients' residual functionality, limit disease progression, and improve quality of life for both patients and their caregivers. This longitudinal and multicenter study applies innovative cognitive telerehabilitation (TR) methods and evaluates their impact on functional parameters obtained with high-density electroencephalogram (HD-EEG) and resting-state functional magnetic resonance imaging (rsFMRI). The goal is to identify neurophysiological correlates of the effects of three different cognitive TR in individuals with MCI due to neurodegenerative conditions. The study aims to: * Identify correlations between improvement in cognitive performance and functional brain data. * Use acquired knowledge to develop neurologically guided TR approaches for broader use. The research will include patients diagnosed with MCI associated with neurodegenerative diseases. Primary outcome measures include changes in resting-state brain connectivity assessed through HD-EEG and rsFMRI. Secondary outcomes involve the assessment of changes in neuropsychological measures, caregiver burden, immediately after rehabilitation and after longitudinal follow-up. The study is designed to last 30 months, with follow-up assessments at three time points. The primary outcomes will be evaluated using rsFMRI and HD-EEG instrumental acquisitions, the secondary outcomes will be evaluated using clinical assessments and neuropsychological tests.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
Italy
IRCCS Mondino Foundation
RECRUITING
Pavia
Contact Information
Primary
Cristina Tassorelli, MD
cristina.tassorelli@unipv.it
0382380419
Backup
Silvia P Caminiti, PhD
silviapaola.caminiti@unipv.it
0382380419
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 110
Treatments
Experimental: Network-based Cognitive Training (NBCT)
The training will be delivered through a virtual platform for TR.
Experimental: Home-based Cognitive Rehabilitation (HomeCoRe)
The training will be delivered through a touch-screen laptop in a home-based setting.
Experimental: Semantic Memory Rehabilitation Training (SMRT)
The training will be delivered through TR with the assistance of an online therapist.
Sham_comparator: Unstructured Home-based Cognitive Stimulation (Control)
The Control stimulation will be delivered through TR with therapist assistance.
Sponsors
Leads: University of Pavia
Collaborators: University of Rome Tor Vergata, University of Parma, University of Bologna

This content was sourced from clinicaltrials.gov