Safety and Efficacy of tDCS in Pediatric DoC (tDCS-DoC-Ped)
Disorder of Consciousness
About this trial
This is an interventional treatment trial for Disorder of Consciousness focused on measuring Pediatric population, tDCS, disorder of consciousness
Eligibility Criteria
Inclusion Criteria: Ages between 4 and 17; prolonged condition (>3 and <12 months) of MCS and VS by severe brain injury; admission to the paediatric rehabilitation department of the Don Carlo Gnocchi Foundation in Florence; central nervous system drug therapy stable for at least one week; stable DoC (i.e. no change in DoC diagnosis detected by 2 consecutive CRS-Rs performed one week apart); Signature of informed consent by the legal representative. Exclusion Criteria: Presence of extensive focal lesions in the left dorsolateral prefrontal cortex (DLPFC); radiological evidence of blood collection/liquid collection/other between the DLPFC and the anode placement site; seizures in the previous month; seizures and/or intermittent epileptiform discharges observed at the extended EEG during the screening phase or at any of the EEG recordings during participation in the study; Presence of established pregnancy; History of cranial surgery, presence of metallic, cochlear or electronic brain implant in the head or neck area, or ventricular shunt to pacemaker; Need for mechanical daytime ventilation; Head circumference less than 43 cm; bilateral severe or profound hypoacusia; Presence of skin lesions in the area to be stimulated; Taking sedative drugs and/or Na or Ca channel blockers or NMDA receptor antagonists presence of peritoneal ventricle shunt in the stimulated area (prefrontal cortex); serious clinical conditions that may influence the clinical diagnosis (e.g. severe liver failure or kidney).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active Comparator - real tDCS
Sham Comparator - sham tDCS
real tDCS: anodal transcranial direct current stimulation were delivered over the left DLPF cortex in patients
sham transcranial direct current stimulation were delivered over the left DLPF cortex in patients.