Minimally Conscious State Clinical Trial
Official title:
Efficacy of Thalamic Stimulation in the Treatment of Patients in Vegetative State and Minimally Conscious State From at Least Six Months. A Pilot Study
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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