Spatiotemporal Entrainment Neuromodulation Targeting Cerebello-Cerebral Circuits to Enhanc
The cerebellum is increasingly recognized for its crucial role in high-level cognitive processes, particularly in the domain of social cognition and action prediction. Disruptions in cerebellar circuits can lead to significant impairments in anticipating others' intentions and behaviors, affecting daily social interact
| Condition(s) | Cerebellar Degeneration, Cerebellar Malformation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The cerebellum is increasingly recognized for its crucial role in high-level cognitive processes, particularly in the domain of social cognition and action prediction. Disruptions in cerebellar circuits can lead to significant impairments in anticipating others' intentions and behaviors, affecting daily social interactions. This randomized, double-blind, sham-controlled trial protocol investigates the combined effects of personalized cerebellar High-Definition transcranial Alternating Current Stimulation (HD-tACS) and Immersive Virtual Reality (IVR) training on social prediction abilities. The study involves two clinical populations: adolescents and young adults with congenital cerebellar malformations (CM) and adults with acquired neurodegenerative cerebellar atrophy (CA). Participants un |
| Who can participate | Inclusion Criteria for patients with cerebellar malformation include: * Documented malformations confined to the cerebellum confirmed by a 3T brain MRI scan; * Age ranging from 12 to 32 years old; * IQ \>= 50; * Absence of extra-cerebellar malformations on conventional brain MRI scan. Inclusion Criteria for patients with degenerative cerebellar atrophy include: * Evidence of diffuse cerebellar atrophy; * More than 6 months of illness; * IQ \>=75; * Absence of any cortical lesion on conventional brain MRI scans Exclusion Criteria for both groups include: * Presence of severe motor and visual impairments, as well as neurodevelopmental (i.e., autism), neurological or psychiatric disorders that could interfere with task execution and protocol compliance; * Presence of any contraindication for |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | I.R.C.C.S. Fondazione Santa Lucia |
| Locations | Pavia, Italy; Roma, Italy |
| Start date | 2025-01-15 |
| NCT ID | NCT07500103 |
| Official listing | https://clinicaltrials.gov/study/NCT07500103 |