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Effects of Telerehabilitation on Brain Network Connectivity

NCT06278818 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-02-26

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Cognitive Telerehabilitation

Cognitive training specifically designed to promote cognitive functions in early stages of neurodegenerative conditions.

OTHER

Control Condition

This activity is commonly used as a control condition to test the effectiveness of innovative rehabilitative treatments.

Sponsors & Collaborators

  • University of Parma

    collaborator OTHER

  • University of Bologna

    collaborator OTHER

  • University of Rome Tor Vergata

    collaborator OTHER

  • University of Pavia

    lead OTHER

Principal Investigators

  • Cristina Tassorelli, MD · University of Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2024-06-07
Completion
2026-03-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06278818 on ClinicalTrials.gov