Locked-In Syndrome
Conditions
Keywords
Brain-Computer Interface, Motor Cortex, Dorsolateral Prefrontal Cortex, Quality of Life
Brief summary
In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. These brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.
Detailed description
In this pilot study we will provide locked-in people with a new means of communication which has not been possible up to now. For the first time, we will test whether we can record and decode neural signals obtained directly from the brain, for control over a computer. The target population is people with locked-in syndrome. For these patients there is no technique available to allow them to communicate unaided. We have developed a brain-computer interface (BCI) system that can read activity directly from the brain, and can convert the activity to a digital switch. The system, called the Utrecht Neural Prosthesis (UNP), consists of an implantable amplifier for electrical brain signals, a set of electrodes positioned on the surface of the brain and a wireless receiver, placed outside of the body. A dedicated computer will convert the signals to electrical pulses for standard Assistive Technology devices. The UNP can in principle enable the patient to engage in any activity that is offered by commercial Assistive Technology companies that can be performed with switch signals, for instance operating home apparatus or writing text. Most importantly, we aim to achieve unsupervised function of the BCI, meaning that the patient will be able to use it at home without the aid of researchers or other experts (but with minimal caregiver assistance).
Interventions
Implant electrodes and sensing device and use for control of Assistive Technology
Sponsors
UMC Utrecht
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 75 * 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 * Rudimentary form of communication possible (e.g. through assistive technology, eye blinks or eye movements, severely impaired speech) * Mentally and physically capable of giving informed consent * Lives in or close to the Netherlands * MR compatible * able to lie flat in the scanner * no metal objects in or attached to the body * no claustrophobia * Visus (largely) intact * Cognition intact (IQ\>80) * Compatible with implantation procedure * good respiratory function or stable respiratory situation using ventilation assistance
Exclusion criteria
* Strong and frequent spasms * Vital indication for blood thinners * Current brain tumor or history of tumor resection * Quick medical or neurological deterioration * Patients who are considered legally incapable (and who therefore will not be able to give informed consent) * Current or recent psychiatric disorder * Catabolic state * Allergy to the materials of the implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance | up to 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Device Satisfaction | 8 years | The Québec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.0, a self-report or interview-based scale, designed to evaluate a person's satisfaction with a wide range of assistive technology, consisting of a 12 questions scale from 1(very dissatisfied) - 4(very satisfied). Reported is mean score. Higher scores are better. |
| Effects Device on Quality of Life | 3 years | Psychosocial Impact of Assistive Devices Scale (PIADS), a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. Score range is -3 to 3, larger values indicate a more positive effect of the device. Outcome is averaged over three domains (competence, adaptability, and self-esteem) |
| Quality of Life by Scoring Subjective Well-being in ACSA Score | 4.5 years | Anamnestic Comparative Self-Assessment (ACSA), a self-anchoring rating scale for subjective well-being score, ranges from -5 (worst period in life) to +5 (best period in life). Higher scores are a better outcome. |
| Hours of Use of BCI Device Per Day | Time frame starts when participant receives a system with the full feature set for 24h home use and ends when signal decline starts influencing hours of use per day, an average of 1 year | The hours of use of the BCI device as determined by logging within the home use software. Only hours of use with full featured home use software and appropriate signal amplitude. The period where signal amplitude declined, possibly due to participants disease progression, is not taken into account. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Supervised BCI Performance | up to 28 weeks | 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) |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ECoG (Electrocorticography) Sensing Use ECoG-based Brain Computer interface to control assistive technology
ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | ECoG (Electrocorticography) Sensing | — |
|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 9.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 6 |
| other Total, other adverse events | 5 / 6 |
| serious Total, serious adverse events | 5 / 6 |
Outcome results
Primary
Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance
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.
Time frame: up to 1 year
Population: This is analyzed in the participants who received an implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ECoG (electrocorticography) sensing | Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance | 1 Participants |
Secondary
Effects Device on Quality of Life
Psychosocial Impact of Assistive Devices Scale (PIADS), a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. Score range is -3 to 3, larger values indicate a more positive effect of the device. Outcome is averaged over three domains (competence, adaptability, and self-esteem)
Time frame: 3 years
Population: participant with home use
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ECoG (electrocorticography) sensing | Effects Device on Quality of Life | 2.43 score on a scale |
Secondary
Hours of Use of BCI Device Per Day
The hours of use of the BCI device as determined by logging within the home use software. Only hours of use with full featured home use software and appropriate signal amplitude. The period where signal amplitude declined, possibly due to participants disease progression, is not taken into account.
Time frame: Time frame starts when participant receives a system with the full feature set for 24h home use and ends when signal decline starts influencing hours of use per day, an average of 1 year
Population: participant with home use
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ECoG (electrocorticography) sensing | Hours of Use of BCI Device Per Day | 21.26 hours per day |
Secondary
Patient Device Satisfaction
The Québec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.0, a self-report or interview-based scale, designed to evaluate a person's satisfaction with a wide range of assistive technology, consisting of a 12 questions scale from 1(very dissatisfied) - 4(very satisfied). Reported is mean score. Higher scores are better.
Time frame: 8 years
Population: participant with home use
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ECoG (electrocorticography) sensing | Patient Device Satisfaction | 3.5 score on a scale |
Secondary
Quality of Life by Scoring Subjective Well-being in ACSA Score
Anamnestic Comparative Self-Assessment (ACSA), a self-anchoring rating scale for subjective well-being score, ranges from -5 (worst period in life) to +5 (best period in life). Higher scores are a better outcome.
Time frame: 4.5 years
Population: participant with home use
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ECoG (electrocorticography) sensing | Quality of Life by Scoring Subjective Well-being in ACSA Score | 2 score on a scale |
Other Pre-specified
Supervised BCI Performance
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)
Time frame: up to 28 weeks
Population: only participants that received an implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ECoG (electrocorticography) sensing | Supervised BCI Performance | 3 Participants |