Zeer ernstige verlamming door trauma of ziekte (Locked in syndroom) Locked-in syndrome
Conditions
Interventions
A device will be implanted, to detect and analyze brain signals. After the
surgical implant procedure, feedback is given of brain activity via a visual
display. Successful control over the brain sig
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 - 75 2) Locked-in status (i.e. severely paralyzed with communication problems) - in case of trauma or stroke: at least 1 year after the event - in case of a neuromuscular disease: slow progression allowed 3) Mentally and physically capable of giving informed consent . If at the time of the informed consent procedure (details in 11.2.2) the patient is not capable to unequivocally communicate consent, earlier expressions of the wish to participate after the patient was given information on the study will suffice. 4) Lives in or close to the Netherlands 5) MR compatible* - able to lie flat in the scanner - no metal objects in or attached to the body - no claustrophobia 6) Visus (largely) intact 7) Cognition intact (IQ>80) - In the case of unreliable communication at the time of inclusion, tests of cognitive functioning will not be conducted and results of fMRI analysis will inform the neuropsychologist about the patient*s cognitive ability to understand and follow instructions. 8) Compatible with implantation procedure - good respiratory function or stable respiratory situation using ventilation assistance * Because electrodes are already in place, imaging, electrode placement surgery and strip selection procedures are not relevant for new participants with existing implant.
Exclusion criteria
Exclusion criteria: 1) Strong and frequent spasms 2) Vital indication for blood thinners 3) Current brain tumor or history of tumor resection 4) Quick medical or neurological deterioration 5) Patients who are considered legally incapable (and who therefore will not be able to give informed consent), unless there is evidence of earlier expressions of the will to participate after information about the study was given to the patient (eg legal document) 6) Current or recent psychiatric disorder 7) Catabolic state 8) Allergy to the materials of the implant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is proficiency of use of the BCI system. For this we recognize three levels of proficiency: First, the level of proficiency described as the primary objective, being unsupervised BCI performance (with system switched on/off by caregiver), with the criterion that the system correctly detects a switch brain signal within 10 sec in a real life, cognitively engaging context, such as operating a spelling device. A formal test has been designed, in which the patient has to copy a 30 character sentence within 30 minutes, with a margin of 20 faulty characters (see Section 8.3.7, Level 2 proficiency). For this test, scanning software is employed. Second, we define lower level of proficiency , which represents a level equivalent to that of the communication channel that the patient had before participation, being supervised BCI performance, where the patient is able to generate switch commands with at least 80 % correct, with the help of a BCI researcher and/or caregiver (using a formal test, see Section 8.3.7, Level 1 proficiency). A third level of control is defined as independent BCI performance, where the patient is capable of switching the BCI system on and off by himself. This requires the highest level of control achievable. Thus, the three levels, in order of proficiency are: 1) Supervised use, dependent on continuous assistance for communication 2) Unsupervised use, ability to communicate without assistance for limited periods 3) Independent use, ability to communicate without assistance at any time of day or night. Note that level 2 is the primary objective of the study, and that only levels 1 and 2 will be tested using formal tests. Success of the study is defined as: At least 50% of participants (3/5) reach level 2 proficiency and can thus communicate effectively as assessed with a formal test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are patient satisfaction (subjective ratings, hours use of BCI system per week, quality of life), and definition of a set of metrics for evaluation of efficacy of the BCI system for a larger clinical trial. | — |
Countries
Netherlands
Outcome results
None listed