NeuroCognitive Communicator: Safety Study

NCT ID: NCT03100110

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2024-04-15

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.

Conditions

Motor Neuron Disease, Amyotrophic Lateral Sclerosis; Tetraplegia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

NeuroCognitive Communicator

Group Type: EXPERIMENTAL

NeuroCognitive Communicator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Utah Array; Blackrock Microsystems NeuroPort; Brain-Computer Interface; Brain-Machine Interface

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Robert Doole, MSc

Role: CONTACT

rdoole@ohri.ca

647-563-3141

Adam J Sachs, MD

Role: CONTACT

asachs@toh.ca

613-798-5555 ext. 14471

Facility Contacts

Robert Doole, MSc

Role: primary

rdoole@ohri.ca

6475633141

Other Identifiers

20170100-01H

Identifier Type: -

Identifier Source: org_study_id