Thalamic Stimulation of Patients in Vegetative or Minimally Conscious State (CATS\)
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|ClinicalTrials.gov Identifier: NCT01027572|
Recruitment Status : Unknown
Verified June 2011 by IRCCS Policlinico S. Matteo.
Recruitment status was: Recruiting
First Posted : December 8, 2009
Last Update Posted : June 27, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Vegetative State Minimally Conscious State||Device: Implantable neurostimulation system (Medtronic)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2012|
Experimental: Thalamic stimulation
Patients in Vegetative or Minimally Conscious State
Device: Implantable neurostimulation system (Medtronic)
Thalamic stimulation will be performed using an implantable neurostimulation system
- Efficacy 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027572
|Contact: Roberto Imberti, MDfirstname.lastname@example.org|
|Contact: Lorenzo Magrassi, MDemail@example.com|
|Istituto di Bioimmagini e Fisiologia Molecolare - CNR||Recruiting|
|Contact: Gabriele EM Biella, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Gabriele EM Biella, MD, PhD|
|Fondazione IRCCS "Casimiro Mondino"||Recruiting|
|Pavia, Italy, 27100|
|Contact: Stefano Bastianello, MD email@example.com|
|Principal Investigator: Stefano Bastianello, MD|
|Fondazione IRCCS "Salvatore Maugeri"||Recruiting|
|Pavia, Italy, 27100|
|Contact: Caterina Pistarini, MD firstname.lastname@example.org|
|Principal Investigator: Caterina Pistarini, MD|
|Study Chair:||Roberto Imberti, MD||Fondazione IRCCS Policlinico S. Matteo - Pavia - Italy|
|Study Chair:||Lorenzo Magrassi, MD||Fondazione IRCCS Policlinico S. Matteo, Pavia and University of Pavia - Italy|