Actively Recruiting
Spatiotemporal Entrainment Neuromodulation Targeting Cerebello-Cerebral Circuits to Enhance Cognitive and Social Rehabilitation in Cerebellar Diseases
Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2026-03-30
60
Participants Needed
2
Research Sites
115 weeks
Total Duration
On this page
Sponsors
I
I.R.C.C.S. Fondazione Santa Lucia
Lead Sponsor
I
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 undergo eight daily sessions of IVR training designed to enhance internal models of social events through interactive scenarios. Simultaneously, they receive either active or sham HD-tACS delivered at their Individual Gamma Frequency (IGF), determined via baseline EEG. The primary outcomes include behavioral responses to context-based social prediction tasks (action intentions, emotions, and personality traits). Secondary outcomes encompass electrophysiological measures, neuropsychological functioning, and adaptive behavior. By integrating neuromodulation with embodied virtual experiences, the project aims to facilitate cerebello-cerebral plasticity and provide a novel transdiagnostic rehabilitative approach for socio-cognitive impairments.
CONDITIONS
Official Title
Spatiotemporal Entrainment Neuromodulation Targeting Cerebello-Cerebral Circuits to Enhance Cognitive and Social Rehabilitation in Cerebellar Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For cerebellar malformation patients: documented cerebellar malformations confirmed by 3T brain MRI
- Age between 12 and 32 years
- IQ 50 or higher
- No extra-cerebellar malformations on MRI
- For degenerative cerebellar atrophy patients: evidence of diffuse cerebellar atrophy
- Illness duration longer than 6 months
- IQ 75 or higher
- No cortical lesions on MRI
You will not qualify if you...
- Severe motor or visual impairments
- Neurodevelopmental disorders such as autism
- Neurological or psychiatric disorders interfering with task execution or compliance
- Any contraindication for transcranial alternating current stimulation (tACS)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, Italy, 27100
Actively Recruiting
2
I.R.C.C.S. Fondazione Santa Lucia
Roma, Italy, 00179
Not Yet Recruiting
Research Team
M
Maria Leggio, MD, PhD
CONTACT
R
Renato Borgatti, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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