REstoring CONsciousness with NEurostimulation of the Central Thalamus in patients with a persistent minimally conscious state (RECONNECT): a pilot study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 6

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

• 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 <5 years

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study is the change on the CRS-R and the number of<br /><br>patients that emerges from MCS. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are changes on a subset of additional behavioral scales for<br /><br>patients recovering from coma (PALOC-S, DRS), the effects of DBS treatment on<br /><br>the perceived change of consciousness and its appreciation by family members,<br /><br>and the quality of life and health in family members as measured by the<br /><br>WHOQOL-BREF. Moreover, neurophysiological parameters will be compared between<br /><br>the preoperative and postoperatieve state using MEG. </p><br>