Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01027572
Study type Interventional
Source IRCCS Policlinico S. Matteo
Contact Roberto Imberti, MD
Phone +39-0382-502070
Email r.imberti@smatteo.pv.it
Status Recruiting
Phase Phase 2
Start date July 2009
Completion date July 2012

See also
  Status Clinical Trial Phase
Completed NCT02288533 - Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders N/A
Completed NCT03494218 - Reliability and Validity of the NCS (NCS-R)-Chinese Version N/A
Recruiting NCT02591069 - Vagal Nerve Stimulation in Coma Patients N/A
Active, not recruiting NCT03826407 - Development of a Point of Care System for Automated Coma Prognosis
Completed NCT04687553 - Validation of the Chinese Version of the SECONDs N/A
Completed NCT05536921 - Eye Tracking Technology in the Diagnosis of Neurological Patients
Completed NCT03126929 - Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R N/A
Completed NCT03732092 - The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients
Completed NCT03508336 - The Initiation of Swallowing Can Indicate the Prognosis of DOC
Completed NCT04921683 - The Use of LIFUP in Chronic Disorders of Consciousness N/A
Terminated NCT03367078 - tDCS in Patients With Disorder of Consciousness Due to Severe Acquired Brain Injury
Recruiting NCT04798456 - Aiming for a Better Understanding and Improvement of the Diagnosis and Prognosis of Patients With Disorders of Consciousness Through Multimodal Observations
Not yet recruiting NCT04248946 - Neural, Behavioural, and Clinical Effects of tDCS in PDOC; Feasibility Study N/A
Completed NCT01820923 - Transcranial Brain Stimulation in Vegetative State Patients N/A
Completed NCT00557076 - The Efficacy of Familiar Voice Stimulation During Coma Recovery N/A
Recruiting NCT03910959 - Therapeutic Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State N/A
Recruiting NCT04010838 - Spinal Cord Stimulation in Patients With Disorders of Consciousness N/A
Completed NCT04139239 - Diagnostic Accuracy of the Vegetative and Minimally Conscious State
Recruiting NCT03007784 - Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients Phase 3
Not yet recruiting NCT02566720 - Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study N/A