Timed cerebellar stimulation with immersive virtual reality to boost social prediction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: m.leggio@hsantalucia.it
• Phone: +39 06 49917645

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.