NeuroCognitive Communicator: Safety Study
NCC-1701
NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedStudy Start
First participant enrolled
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2024
CompletedAugust 1, 2022
July 1, 2022
4.9 years
February 21, 2017
July 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of adverse events
Transcutaneous connector will be assessed by physician 3-4 times per week for skull and scalp health and lack of infection. All adverse events associated with the system will be measured.
6 months
Change in quality of life as assessed by McGill Quality of Life questionnaire.
McGill Quality of Life questionnaire will be administered monthly; shortened version will be administered 3-4 times per week.
6 months
Secondary Outcomes (3)
Percentage of allotted time spent with each augmentative and assistive communication technology.
6 months
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.
6 months
Coefficients of neuronal activity covariance matrix and their dependence on task performance.
6 months
Study Arms (1)
NeuroCognitive Communicator
EXPERIMENTALInterventions
Comprises an electrode array in prefrontal cortex, another in motor cortex, Blackrock NeuroPort system and connectors, augmentative assistive communication application, robotic arm, and virtual reality environment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2017
First Posted
April 4, 2017
Study Start
May 13, 2019
Primary Completion
April 15, 2024
Study Completion
April 15, 2024
Last Updated
August 1, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share