Thalamic Stimulation of Patients in Vegetative or Minimally Conscious State (CATS\)

June 24, 2011 updated by: IRCCS Policlinico S. Matteo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Recruiting
        • Istituto di Bioimmagini e Fisiologia Molecolare - CNR
        • Contact:
        • Principal Investigator:
          • Gabriele EM Biella, MD, PhD
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS "Casimiro Mondino"
        • Contact:
        • Principal Investigator:
          • Stefano Bastianello, MD
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS "Salvatore Maugeri"
        • Contact:
        • Principal Investigator:
          • Caterina Pistarini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients stably in VS or MCS from at least 6 months, 10 to 65 years old.
  • Patients must fulfil the neuroimaging criteria described later
  • Patients must fulfil neurophysiologic criteria as described later

Exclusion Criteria:

  • Inability to provide the informed consent by the legal representative
  • Age < 10 years and > 65 years
  • Pregnancy
  • Expected life span < 1 year
  • Presence of infectious disease not treatable
  • Brain pathology not correlated with VS or MCS

Inclusion criteria based on MRI imaging of the brain. The following criteria specify the location and extent of damage to the brain which determine the inclusion or exclusion from the study.

Before inclusion into the study all patients will be submitted to a complete MRI of the brain comprehensive of T1 and T2 weighted and flair sequences. Patients with a history of traumatic injury that were not submitted to cervical MRI at the time or after the initial injury will be submitted to a cervical MRI before admission to the study. A MRI scanner with field strength of at least 1.5 tesla will be used for imaging the brain and the cervical spinal cord. The volumetric extent of the damage will be estimated by using an image analysis program (e.g. IMAGE, NIH) after the neuroradiologist has traced the contour of the injured structures in all MRI images of the brain.

Thalamus: bilateral absence of damage of the centromedian/parafascicularis complex and of the entire area of the intralaminar nuclei. The remaining structures of the thalami should not be damaged for an extent greater than 40% of the total volume of the two thalami.

Frontal lobes: at least one lobe should not be damaged to an extent superior to 20% of the volume. Absence of lesion of the Broca's area in the left (or dominant) hemisphere.

Temporal lobes: absence of damage to the posterior two third of the left or dominant temporal lobe. The extent of the lesions in the remaining structures of the temporal lobes should be less than 70% of the total volume of the lobes.

Parietal lobes: lesion volume in at least one parietal lobe should be less than 30%.

Occipital lobes: lesion volume in at least one occipital lobe should be less than 30%. The visual cortex should be spared in at least one lobe.

Hypothalamus: absence of lesions. Mesencephalon: absence of lesions in the region located between the substantia nigra and the bases of the colliculi. Unilateral lesions ventral to the substantia nigra are permitted.

Pons: absence of lesions unless unilateral and limited to the ventral third of the pons.

Cerebellum: Absence of lesions larger than 80% of the total volume; the deep nuclei of at least one side of the cerebellum should be intact.

Medulla: absence of lesions unless limited to one pyramid. Cervical spinal cord: absence of lesions All patients should be free from hydrocephalus or the hydrocephalus should be treated with a shunt prior to thalamic implant.

Exclusion criteria based on MRI imaging of the brain. All patients who do not fulfill the criteria for inclusion based on MRI imaging of the brain will be excluded.

Inclusion Criteria based on neurophysiologic parameters

  • Patients will be studied by continuous electroencephalography. Patients showing EEG desynchronization for at least 5% of the period studied will be included.
  • Acoustic evoked potentials must be present at least at one side. V wave prolongation will be accepted.
  • Somato-sensory evoked potentials must be present at least at one side. Increased latency of N20 will be accepted.

Exclusion Criteria based on neurophysiologic criteria All patients who do not fulfill the criteria for inclusion based on neurophysiologic parameters will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1, 6, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 7, 2009

First Posted (Estimate)

December 8, 2009

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 24, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RILM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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