chronische bewustzijnsstoornissen Minimally conscious state minimally responsive state
Conditions
Interventions
DBS electrodes will be implanted bilaterally in the central thalamus and
connected to a pulse generator that is placed under the skin of the chest.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Age 18-65 years • Diagnosis of MCS according to CRS-R • The patient is in persistent MCS, i.e. at least 24 months post-injury • MCS is caused by non-progressive traumatic brain injury (TBI) • MCS is treatment-refractory, defined as: - not accompanied by concomitant hydrocephalus or - accompanied by concomitant hydrocephalus that has been adequately treated by permanent cerebrospinal fluid shunting for at least six months with no evidence of improvement in neurobehavioral function in the last two months prior to enrolment and - previous failure of emergence from MCS by treatment with amantadine, levodopa and zolpidem • Independent ventilation • Stable physical condition • Written informed consent by primary family caregivers
Exclusion criteria
Exclusion criteria: • Expectation that patients will not be able to meaningfully interact with the outside world even when consciousness is restored, defined as: - evidence of significant lesions involving cortical language areas (Wernicke's and/or Broca's - area) or brainstem on MRI or - quadriplegia due to spinal cord injury, brainstem injury, or bilateral loss of motor cortex on MRI • Premorbid mental retardation • MRI-incompatible cardiac pacemaker/defibrillator • Intractable seizure disorders (status epilepticus) • Presence of untreated endocrine disturbances (i.e., hyper- or hypothyroidism) or other biochemical disturbances • Medical contraindications for DBS or general anesthesia, and comorbid conditions, including: - non-closed skull due to previous decompressive hemicraniectomy without proper cranioplasty - anatomical barriers for electrode placement on MRI - local, systemic, acute, or chronic infectious illness - severe collagen vascular disorder/bleeding disorders - severe chronic pulmonary disease - life-threatening cardiac arrhythmias - kidney failure or other major organ systems failures - other active neurologic diseases/processes (i.e., multiple sclerosis, Parkinson*s disease, Alzheimer*s disease) - neoplasm with life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the change on the CRS-R and the number of patients that emerges from MCS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are changes on a subset of additional behavioral scales for patients recovering from coma (PALOC-S, DRS), the effects of DBS treatment on the perceived change of consciousness and its appreciation by family members, and the quality of life and health in family members as measured by the WHOQOL-BREF. Moreover, neurophysiological parameters will be compared between the preoperative and postoperatieve state using MEG. | — |
Countries
Netherlands
Outcome results
None listed