NCT07095062 Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome.
| NCT ID | NCT07095062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Friedreich's Ataxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion criteria: * age between 8 and 60 years; * genetic diagnosis of FRDA: presence of guanine-adenine trinucleotide (GAA) expansion in the two alleles of the fratassin gene, GAA1 and GAA2; * score on the Scale for the Assessment and Rating of Ataxia (SARA) \< 30; * ability to take part in a neuropsychological assessment in Italian. Exclusion criteria: * age different from the range 8-60 years; * diagnosis of acquired ataxia or other genetic ataxias; * SARA scale score ≥ 30; * inability to take part in an Italian-language neuropsychological assessment