Actively Recruiting

Phase Not Applicable
Age: 12Years +
All Genders
NCT07500103

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

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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