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NeuroCognitive Communicator: Safety Study (NCC-1701)

Primary Purpose

Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Tetraplegia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NeuroCognitive Communicator
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Motor Neuron Disease, Amyotrophic Lateral Sclerosis focused on measuring Brain-Computer Interface, Brain-Machine Interface, Prefrontal Cortex

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ottawa HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NeuroCognitive Communicator

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 21, 2017
Last Updated
July 28, 2022
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03100110
Brief Title
NeuroCognitive Communicator: Safety Study
Acronym
NCC-1701
Official Title
NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Tetraplegia
Keywords
Brain-Computer Interface, Brain-Machine Interface, Prefrontal Cortex

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NeuroCognitive Communicator
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NeuroCognitive Communicator
Other Intervention Name(s)
Utah Array, Blackrock Microsystems NeuroPort, Brain-Computer Interface, Brain-Machine Interface
Intervention Description
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 Information:
Title
Rate of adverse events
Description
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.
Time Frame
6 months
Title
Change in quality of life as assessed by McGill Quality of Life questionnaire.
Description
McGill Quality of Life questionnaire will be administered monthly; shortened version will be administered 3-4 times per week.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of allotted time spent with each augmentative and assistive communication technology.
Description
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.
Time Frame
6 months
Title
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.
Description
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.
Time Frame
6 months
Title
Coefficients of neuronal activity covariance matrix and their dependence on task performance.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Doole, MSc
Phone
647-563-3141
Email
rdoole@ohri.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Adam J Sachs, MD
Phone
613-798-5555
Ext
14471
Email
asachs@toh.ca
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Doole, MSc
Phone
6475633141
Email
rdoole@ohri.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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NeuroCognitive Communicator: Safety Study

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