NeuroCognitive Communicator: Safety Study (NCC-1701)

• ClinicalTrials.gov Identifier: NCT03100110
• Recruitment Status: Recruiting
• First Posted: April 4, 2017
• Last Update Posted: January 14, 2021
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Motor Neuron Disease, Amyotrophic Lateral Sclerosis; Tetraplegia	Device: NeuroCognitive Communicator	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.
• Actual Study Start Date: May 13, 2019
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: May 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: NeuroCognitive Communicator	Device: NeuroCognitive Communicator; 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.; Other Names: Utah Array; Blackrock Microsystems NeuroPort; Brain-Computer Interface; Brain-Machine Interface

Outcome Measures

Primary Outcome Measures :

1. 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.

2. 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.

Secondary Outcome Measures :

1. Percentage of allotted time spent with each augmentative and assistive communication technology. [ Time Frame: 6 months ]
   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.
2. 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 ]
   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.
3. Coefficients of neuronal activity covariance matrix and their dependence on task performance. [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Robert Doole, MSc; 647-563-3141; rdoole@ohri.ca

Contact: Adam J Sachs, MD; 613-798-5555 ext 14471; asachs@toh.ca

Locations

Canada, Ontario

The Ottawa Hospital; Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contact: Robert Doole, MSc 6475633141 rdoole@ohri.ca

Sponsors and Collaborators

Ottawa Hospital Research Institute

More Information

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03100110
• Other Study ID Numbers: 20170100-01H
• First Posted: April 4, 2017
• Last Update Posted: January 14, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:

Brain-Computer Interface; Brain-Machine Interface; Prefrontal Cortex

Additional relevant MeSH terms:

Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Quadriplegia; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Paralysis; Neurologic Manifestations