NCT06278818

Effects of Telerehabilitation on Brain Network Connectivity

Name: Clinical Trial NCT06278818
Creator: University of Pavia
Keywords: Mild Cognitive Impairment, Cognitive Telerehabilitation, behavioral, clinical trial, Italy

Neural and Clinical Correlates of Rehabilitation in Neurodegenerative Conditions

University of Pavia·ClinicalTrials.gov·behavioralRecruiting

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Study focus

Disease/Condition: Mild Cognitive Impairment
Drug/Device/Intervention: Cognitive Telerehabilitation
Study type: Interventional
Intervention type: behavioral

Sponsor & location

Primary sponsor: University of Pavia
Location: Pavia, Italy

Timeline & enrollment

Phase: N/A
Start date: Dec 07, 2023
End date: Mar 01, 2026
Enrollment: 110 participants

Primary outcome

Changes in resting-state brain networks functional connectivity after NBTC treatment,Changes in resting-state EEG coherence after NBTC treatment,Changes in resting-state EEG coherence after HomeCore treatment,Changes in resting-state brain networks functional connectivity after SMRT treatment

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.

ICD-10 classifications

Mild cognitive disorderAlzheimer diseaseDementia in other specified diseases classified elsewhereDementia in other diseases classified elsewhereDementia in Alzheimer disease

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06278818
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06278818 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Pavia and is currently Recruiting. The study focuses on Mild Cognitive Impairment. Target enrollment is 110 participants.

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