NCT03100110

NeuroCognitive Communicator: Safety Study

NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-13
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2017-04-04
• Last updated: 2022-08-01

Locations

1 site across 1 country: Canada