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Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome.

NCT07095062 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-31

No results posted yet for this study

Summary

Prospective, exploratory, multicenter pilot study investigating the structural and functional connectome in patients with Friedreich's Ataxia (FRDA) using high-density electroencephalogram (HD-EEG). The aim is to identify neurophysiological biomarkers and analyze the relationship between cortical connectivity, cognitive functioning, and clinical severity, particularly in response to rehabilitation treatment.

Conditions

Interventions

DEVICE

HD-EEG recordings, combined with cognitive and motor assessment

Participants will undergo high-density EEG (HD-EEG) recordings under two conditions: at rest and while performing an upper limb motor task. The data obtained will be used to reconstruct source cortical activity and derive patterns of functional connectivity, using advanced neurophysiological analysis techniques, including the Avalanche Transition Matrix (ATM). In addition, patients will complete a neuropsychological assessment and participate in an intensive multidisciplinary rehabilitation program lasting 3 to 4 weeks, depending on age. The intervention aims to assess changes in the functional organization of the brain before and after treatment, as well as one year later, in order to explore potential biomarkers of disease progression.

Sponsors & Collaborators

  • IRCCS Eugenio Medea

    lead OTHER

Principal Investigators

  • Gabriella Paparella, Medical Doctor · IRCCS E. Medea / Associazione la Nostra Famiglia

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-07
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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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 NCT07095062 on ClinicalTrials.gov