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Vegetative StatePhase 2CATS\NCT01027572

Thalamic Stimulation of Patients in Vegetative or Minimally Conscious State

A Phase 2 study testing Implantable neurostimulation system (Medtronic) in people with Vegetative State and Minimally Conscious State, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 65 years
Conditions the study is for
Vegetative State, Minimally Conscious State
What is being tested?
Implantable neurostimulation system (Medtronic)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
3 sitesItaly
Study dates
Jul 2009to Jul 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Roberto Imberti, MD contact

+39-0382-502070

r.imberti@smatteo.pv.it

Lorenzo Magrassi, MD contact

l.magrassi@smatteo.pv.it

Italy3 sites, 3 recruiting

  • Istituto di Bioimmagini e Fisiologia Molecolare - CNR

    Milan

    Gabriele EM Biella, MD, PhD, gabriele.biella@ibfm.cnr.it

    Gabriele EM Biella, MD, PhD

    Recruiting

  • Fondazione IRCCS "Casimiro Mondino"

    Pavia, 27100

    Stefano Bastianello, MD, stefano.bastianello@mondino.it

    Stefano Bastianello, MD

    Recruiting

  • Fondazione IRCCS "Salvatore Maugeri"

    Pavia, 27100

    Caterina Pistarini, MD, caterina.pistarini@fsm.it

    Caterina Pistarini, MD

    Recruiting

Other trials in Italy

About this study

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.

Read more

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.

Being tested
Implantable neurostimulation system (Medtronic)
Keywords
Vegetative state, Minimally conscious state, Thalamic stimulation
Medical subject headings
Persistent Vegetative State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable neurostimulation system (Medtronic)Device

    Thalamic stimulation will be performed using an implantable neurostimulation system

Study groups in NCT01027572
Study groupRoleWhat they receive
Thalamic stimulationExperimentalPatients in Vegetative or Minimally Conscious State
Receives: Device: Implantable neurostimulation system (Medtronic)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1, 6, 12 months

Secondary outcomes (1)

  1. 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.

    Measured: 1, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2011 (estimated)
  4. Study completionJul 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01027572
Sponsor's protocol ID
RILM
Acronym
CATS\
Status last verified
Jun 2011
First submitted
1 Dec 2009
Last updated
27 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Schiff ND, Giacino JT, Kalmar K, Victor JD, Baker K, Gerber M, Fritz B, Eisenberg B, Biondi T, O'Connor J, Kobylarz EJ, Farris S, Machado A, McCagg C, Plum F, Fins JJ, Rezai AR. Behavioural improvements with thalamic stimulation after severe traumatic brain injury. Nature. 2007 Aug 2;448(7153):600-3. doi: 10.1038/nature06041.

    PubMed 17671503

  • Lombardi F, Gatta G, Sacco S, Muratori A, Carolei A. The Italian version of the Coma Recovery Scale-Revised (CRS-R). Funct Neurol. 2007 Jan-Apr;22(1):47-61.

    PubMed 17509244

  • Yamamoto T, Kobayashi K, Kasai M, Oshima H, Fukaya C, Katayama Y. DBS therapy for the vegetative state and minimally conscious state. Acta Neurochir Suppl. 2005;93:101-4. doi: 10.1007/3-211-27577-0_17.

    PubMed 15986737

  • Magrassi L, Maggioni G, Pistarini C, Di Perri C, Bastianello S, Zippo AG, Iotti GA, Biella GE, Imberti R. Results of a prospective study (CATS) on the effects of thalamic stimulation in minimally conscious and vegetative state patients. J Neurosurg. 2016 Oct;125(4):972-981. doi: 10.3171/2015.7.JNS15700. Epub 2016 Jan 8.

    PubMed 26745476

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Implantable neurostimulation system (Medtronic) in people with Vegetative State and Minimally Conscious State, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Roberto Imberti, MD (+39-0382-502070, r.imberti@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01027572, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.

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