Spatiotemporal Entrainment Neuromodulation Targeting Cerebello-Cerebral Circuits to Enhance Cognitive and Social Rehabilitation in Cerebellar Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorI.R.C.C.S. Fondazione Santa Lucia

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 tACS.

Trial design

Treatments tested in this trial

  • EEg-guided High-Definition transcranial alternate current stimulation (HD-tACS)
  • Immersive Virtual Reality (IVR) Social Prediction training

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

I.R.C.C.S. Fondazione Santa Lucia

Lead sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Collaborator