NCT01027572

Thalamic Stimulation of Patients in Vegetative or Minimally Conscious State

Efficacy of Thalamic Stimulation in the Treatment of Patients in Vegetative State and Minimally Conscious State From at Least Six Months. A Pilot Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vegetative State
• Minimally Conscious State

Interventions

Type	Name	Description
DEVICE	Implantable neurostimulation system (Medtronic)	Thalamic stimulation will be performed using an implantable neurostimulation system

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-07-01
• Completion: 2012-07-01
• First posted: 2009-12-08
• Last updated: 2011-06-27

Locations

3 sites across 1 country: Italy