Timed cerebellar stimulation with immersive virtual reality to boost social prediction

Spatiotemporal Entrainment as Innovative Neuromodulation Targeting Cerebello-cerebral Circuits for Enhancing Rehabilitation Outcomes of Cognitive and Social Skills in Progressive and Acquired Cerebellar Diseases

This trial will try personalized cerebellar HD-tACS together with immersive virtual reality to improve social prediction in adolescents and young adults with congenital cerebellar malformations and in adults with degenerative cerebellar atrophy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: I.R.C.C.S. Fondazione Santa Lucia (other)
• Locations: 2 sites (Pavia and 1 other locations)
• Trial ID: NCT07500103 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, sham-controlled trial run in two clinical cohorts (30 patients with congenital cerebellar malformations and 30 with degenerative cerebellar atrophy). Participants receive eight consecutive daily 1-hour immersive virtual reality sessions targeting social prediction while simultaneously receiving either EEG-guided active High-Definition transcranial Alternating Current Stimulation (HD-tACS) to the cerebellum or sham stimulation. Allocation is 1:1 active versus sham using computer-generated blocked randomization with blinding of participants and assessors. Outcomes are measured at baseline, immediately after the 8-day intervention, and at a two-month follow-up to examine short- and medium-term effects.

Who should consider this trial

Good fit: Ideal candidates are people aged 12–32 with congenital cerebellar malformations (IQ ≥50) or adults with degenerative cerebellar atrophy (IQ ≥75) who have predominantly cerebellar damage, intact enough motor/visual function to perform the tasks, and no contraindications to tACS.

Not a fit: Patients with extra-cerebellar lesions, severe motor or visual impairments, diagnosed autism or other neurodevelopmental/psychiatric conditions that would prevent task participation, or any contraindication to tACS are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could improve patients' ability to anticipate others' intentions and enhance everyday social interactions.

How similar studies have performed: Small prior studies suggest cerebellar neuromodulation and virtual-reality training can alter networks and improve some cognitive functions, but the combined EEG-guided HD-tACS plus immersive social VR approach in cerebellar patients is largely novel.

Eligibility criteria

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 tACS.

Where this trial is running

Pavia and 1 other locations

• IRCCS National Neurological Institute "C. Mondino" Foundation — Pavia, Italy (RECRUITING)
• I.R.C.C.S. Fondazione Santa Lucia — Roma, Italy (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Maria Leggio, MD, PhD — I.R.C.C.S. Fondazione Santa Lucia
• Study coordinator: Maria Leggio, MD, PhD

Conditions: Cerebellar Degeneration, Cerebellar Malformation, Cerebellum, Social prediction, tACS, Virtual Reality