Recruiting

NeuroCognitive Communicator

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03100110

Conditions

Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Tetraplegia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

NeuroCognitive Communicator

Study Details

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 ID

NCT03100110

Start date

May 13, 2019

Status verified date

Jul, 2022

Completion date

Apr 15, 2024

Anticipated

Primary completion date

Apr 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: NeuroCognitive Communicator

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.

Primary outcome measure

  • Rate of adverse events [ Time Frame: 6 months ]
  • Change in quality of life as assessed by McGill Quality of Life questionnaire. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Robert Doole, MSc

647-563-3141rdoole@ohri.ca

Adam J Sachs, MD

613-798-5555asachs@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Robert Doole, MSc

6475633141rdoole@ohri.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Aug 1, 2022

Last verified

Jul, 2022

Keywords

  • Brain-Computer Interface
  • Brain-Machine Interface
  • Prefrontal Cortex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2022-08-01.