Motor Neuron Disease, Amyotrophic Lateral SclerosisNCC-1701NCT03100110
NeuroCognitive Communicator: Safety Study
A study testing NeuroCognitive Communicator in people with Motor Neuron Disease, Amyotrophic Lateral Sclerosis and Tetraplegia, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Tetraplegia
- What is being tested?
- NeuroCognitive Communicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 13 May 2019to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Robert Doole, MSc, 6475633141, rdoole@ohri.ca
About this study
Official title: NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.
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.
- Being tested
- NeuroCognitive Communicator
- Keywords
- Brain-Computer Interface, Brain-Machine Interface, Prefrontal Cortex
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroCognitive CommunicatorDevice
Also called Utah Array, Blackrock Microsystems NeuroPort, Brain-Computer Interface, Brain-Machine Interface
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.
| Study group | Role | What they receive |
|---|---|---|
| NeuroCognitive Communicator | Experimental | Not described Receives: Device: NeuroCognitive Communicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 6 months
Secondary outcomes (3)
Percentage of allotted time spent with each augmentative and assistive communication technology.
At the end of most experimental sessions, the participant will have time to operate the NCC to control augmentative and assistive communication (AAC) technologies such as robotic arms or spellers. We will measure the percentage of allotted time that the participant spends operating each AAC technology, or choosing not to operate any AAC technology. The data will be aggregated across all AAC sessions with time allotted to AAC operation.
Measured: 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.
Participants will perform repeated trials of experimental tasks designed to activate recorded brain regions. Task progression will be modulated by neuronal activity. Successful completion of the task will require volitional modulation of neuronal activity. Task performance will be quantified by the information transfer rate which is calculated from the number of bits of information communicated by each trial's selection(s) and the amount of time it took to complete a trial.
Measured: 6 months
Coefficients of neuronal activity covariance matrix and their dependence on task performance.
Neuronal activity time series covary across neurons within a brain region and across brain regions. The degree of covariance will be recorded in the coefficients of the covariance matrix, scaled from -1 to +1. The covariance matrix will be recorded under different task conditions.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start13 May 2019
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Neuron Disease, Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100110
- Sponsor's protocol ID
- 20170100-01H
- Acronym
- NCC-1701
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2017
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.
- ClinicalTrials.gov ID
- NCT03100110
- Acronym / sponsor ID
- NCC-1701 / 20170100-01H
- Keywords
- Brain-Computer Interface, Brain-Machine Interface, Prefrontal Cortex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeuroCognitive Communicator | Experimental | Device: NeuroCognitive Communicator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroCognitive CommunicatorAlso: Utah Array, Blackrock Microsystems NeuroPort, Brain-Computer Interface, Brain-Machine InterfaceComprises 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. | Device | NeuroCognitive Communicator |
Primary outcome
Rate of adverse events
Time frame: 6 months
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.
Change in quality of life as assessed by McGill Quality of Life questionnaire.
Time frame: 6 months
McGill Quality of Life questionnaire will be administered monthly; shortened version will be administered 3-4 times per week.
3 secondary outcomes
Percentage of allotted time spent with each augmentative and assistive communication technology.
Time frame: 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.
Time frame: 6 months
Coefficients of neuronal activity covariance matrix and their dependence on task performance.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroCognitive Communicator in people with Motor Neuron Disease, Amyotrophic Lateral Sclerosis and Tetraplegia, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Doole, MSc (647-563-3141, rdoole@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022; AzTrials last refreshed its copy on 26 Oct 2026.