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| Name | Class |
|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
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The goal of this observational study is to test the effectiveness of quantitative early biomarkers in the sleep electroencephalogram (EEG), namely sleep spindles, as predictors of early sensorimotor maturation and long-term motor outcome. Spindles are discrete events, prominent over sensorimotor areas, that reflect motor learning overnight consolidation. They represent a potential marker for the investigation of altered early sensorimotor reorganization and long-term motor outcomes in the case of neuromotor pathologies. To test this hypothesis, we will validate the prognostic accuracy of a semi-automated EEG sleep-spindles analysis in two clinical populations: 1) infants with a perinatal brain lesion, at risk of Cerebral Palsy (CP), 2) infants with Spinal muscular atrophy type 1 (SMA1), a neuromuscular disease detectable at birth with variable response to early pharmacological treatment. A group of typically developing infants (at very low neurological risk) will be enrolled in the study as control group. All participants will undergo two sleep EEG recordings at 2-5 months (T1) and 12 months (T2), respectively. Short-term neuromotor outcome will be evaluated at T1 and T2, through standard and validated assessment. Long-term neuromotor development will be defined at 18 months (T3; i.e. CP vs NO CP; SMA treatment responders vs No responders). Primary clinical and motor outcomes will be used for estimating the effectiveness of spindles' features at T1 and T2 as predictors of later clinical and motor outcomes at T3. EEG sleep features will be considered both cross-sectionally, at each time point (T1, and T2), and from a longitudinal perspective. Differences in the EEG sleep-spindle features will be evaluated within- and between-groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants at risk of Cerebral Palsy | N= 20, Infants at risk of Unilateral Cerebral Palsy (UCP); N= 20, Infants at risk of Bilateral Cerebral Palsy (BCP). | ||
| Infants with diagnosis of SMA1 | N=20, Infants with a diagnosis of SMA type 1. | ||
| Infants at very low neurodevelopmental risk (control group) | N=20, Infants born preterm or at term in absence of perinatal neurological complications, therefore a very low neurodevelopmental risk. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical dichotomous outcome | For infants with perinatal brain damage, the primary outcome will be the diagnosis of CP: CP-YES vs CP-NO. For infants with SMA, the primary outcome will be the response to treatment: responders (SMA-R) vs non-responders (SMA-NR). | 18 (+/- 3) months |
| Sleep EEG (T1,T2) - quantitative sleep spindles analysis | Primary predictive measure of the study | 2-5 months, 12 (+/- 1) months |
| Measure | Description | Time Frame |
|---|---|---|
| General Movements Assessment (GMA; T1) | Short-term motor outcome | 2-5 months |
| Peabody Developmental Motor Scale (PDMS-II; T2 and T3) | Long-term motor outcome |
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Inclusion Criteria:
Exclusion Criteria (apply all groups):
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| Name | Affiliation | Role |
|---|---|---|
| Viviana Marchi, MD, PhD | IRCCS Fondazione Stella Maris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Milan | MI | Italy | |||
| IRCCS Fondazione Stella Maris |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35445398 | Background | Marchi V, Rizzi R, Nevalainen P, Melani F, Lori S, Antonelli C, Vanhatalo S, Guzzetta A. Asymmetry in sleep spindles and motor outcome in infants with unilateral brain injury. Dev Med Child Neurol. 2022 Nov;64(11):1375-1382. doi: 10.1111/dmcn.15244. Epub 2022 Apr 20. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 12 (+/- 1) months, 18 (+/- 3) months |
| Hammersmith Infant Neurological Examination (HINE; T1, T2 and T3) | Clinical short- and long-term outcome | 2-5 months, 12 (+/- 1) months, 18 (+/- 3) months |
| Calambrone |
| PI |
| 56128 |
| Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Italy |