Thalamic Stimulation of Patients in Vegetative or Minimally Conscious State

NCT01027572 | Unknown Phase 2 DMC

• 1 other identifier: RILM
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Vegetative state; Minimally conscious state; Thalamic stimulation

Outcome Measures

Primary Outcomes (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.

  1, 6, 12 months

Secondary Outcomes (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.

  1, 6, 12 months

Study Arms (1)

Thalamic stimulation

EXPERIMENTAL

Patients in Vegetative or Minimally Conscious State

Device: Implantable neurostimulation system (Medtronic)

Interventions

Implantable neurostimulation system (Medtronic) DEVICE

Thalamic stimulation will be performed using an implantable neurostimulation system

Thalamic stimulation

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (3)

Istituto di Bioimmagini e Fisiologia Molecolare - CNR

Milan, Italy

RECRUITING

Fondazione IRCCS "Casimiro Mondino"

Pavia, 27100, Italy

RECRUITING

Fondazione IRCCS "Salvatore Maugeri"

Pavia, 27100, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 17671503 BACKGROUND

• 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.

  PMID: 17509244 BACKGROUND

• 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.

  PMID: 15986737 BACKGROUND

• 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.

  PMID: 26745476 DERIVED

MeSH Terms

Conditions

Persistent Vegetative State

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Roberto Imberti, MD

CONTACT

+39-0382-502070; r.imberti@smatteo.pv.it

Lorenzo Magrassi, MD

CONTACT

l.magrassi@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 8, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

IT (3)