Rationale. The investigators hypothesize that bilateral electrical central thalamic stimulation of patients in Vegetative State and Minimally Conscious State from at least 6 months could improve the level of responsiveness. Aims. Evaluate the efficacy of bilateral electrical central thalamic stimulation in patients in Vegetative State and Minimally Conscious State. Study Design. Patients in Vegetative State and Minimally Conscious State from at least 6 months because of traumatic brain injury, hypoxic or ischemic brain injury will be evaluated to confirm the diagnosis according to the recent literature criteria. Then patients will be investigated by magnetic resonance (MRI), EEG and evoked potentials to evaluate eligibility. Patients included into the study will be implanted with electrodes, targeting the centromedian/parafascicularis nucleus complex of the thalamus bilaterally. In the following months patients will be repeatedly evaluated using the CRS-R and Coma/Near Coma scales and the neurophysiologic parameters (EEG, evoked potentials) to assess the effects of thalamic stimulation. fMRI,DTI and MRS will be performed prior and after thalamic stimulation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Thalamic stimulation will be performed using an implantable neurostimulation system
Istituto di Bioimmagini e Fisiologia Molecolare - CNR
Milan, Italy
RECRUITINGFondazione IRCCS "Casimiro Mondino"
Pavia, Italy
RECRUITINGFondazione IRCCS "Salvatore Maugeri"
Pavia, Italy
RECRUITINGEfficacy of thalamic stimulation evaluated by the administration of the CRS-R and Coma/Near Coma scales and comparing the results obtained with those of the pre-implant evaluation.
Time frame: 1, 6, 12 months
Changes in the length of desynchronization performed by continuous EEG recording and spectral analysis. Evaluate which patients in Vegetative State and Minimally Conscious State can benefit from central thalamic stimulation.
Time frame: 1, 6, 12 months
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