Clinical trial NCT03100110: NeuroCognitive Communicator: Safety Study
Official title: NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Tetraplegia
Keywords: Brain-Computer Interface
Brain-Machine Interface
Prefrontal Cortex
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Individuals suffering from tetraplegia as a result of cervical spinal cord injury, brainstem stroke, or amyotrophic lateral sclerosis (ALS) cannot independently perform tasks of daily living. In many cases, these conditions do not have effective therapies and the only intervention is the provision of assistive devices to increase independence and quality of life. However, currently available devices suffer from usability issues and are limiting for both the patient and caregiver. One of the most progressive alternative strategies for assistive devices is the use of brain-computer interface (BCI) technology to translate intention signals directly from sensors in the brain into computer or device action. Preclinical primate research and recent human clinical pilot studies have demonstrated success in restoring function to disabled individuals using sensors implanted directly in motor regions of the brain. Other preclinical primate research has demonstrated effective intention translation from sensors implemented in cognitive regions of the brain and that this information complements information from the motor regions. The current proposal seeks to build on these studies and to test the safety aspects related to implanting two sensors, each a microelectrode array, into both the motor and cognitive regions of the brain in motor impaired humans. Secondary objectives include feasibility evaluation of the complementary sensors in their ability to support effective assistive communication.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of a complete or incomplete cervical spinal cord injury, with stable neurological deficits greater than 1 year, or ALS with equivalent degree of deficit.
* Maintain some level of communication, enough to independently provide informed consent for the study.
* Deemed healthy for surgery.
* Good psychological and social stability.
* Prospective participants with ALS must already have an advanced directive with regard to ventilation.
* Live within a one-hour travel duration of the site.

Exclusion Criteria:

* Presence of previous certain implanted devices.
* In the opinion of the investigator, the presence of other serious disease or disorder that could affect ability to participate in this study.
* Ongoing participation in another clinical trial.
* Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise (eg. chronic corticosteroid use, immunomodulators, chemotherapy).
* Presence of clinical depression that is not medically optimized, as screened by a neuropsychologist on our team.
* Presence of cognitive deficits, as assessed by a neuropsychologist on our team, that would preclude completion of some cognitively challenging tasks.
* The participant has plans to move outside the study radius within the study period.

Primary outcomes:
measure: Rate of adverse events
timeFrame: 6 months
measure: Change in quality of life as assessed by McGill Quality of Life questionnaire.
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of allotted time spent with each augmentative and assistive communication technology.
timeFrame: 6 months
measure: Information transfer rate (measured in bits per second) achieved by each participant calculated during closed-loop operation of the neuroprosthetic device, aggregated across trials within a task.
timeFrame: 6 months
measure: Coefficients of neuronal activity covariance matrix and their dependence on task performance.
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
References: