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NeuroCognitive Communicator: Safety Study (NCC-1701)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03100110
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE February 21, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date August 1, 2022
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date April 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NeuroCognitive Communicator: Safety Study
Official Title  ICMJE NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Motor Neuron Disease, Amyotrophic Lateral Sclerosis
  • Tetraplegia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: NeuroCognitive Communicator
Intervention: Device: NeuroCognitive Communicator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)		 2
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2024
Estimated Primary Completion Date April 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robert Doole, MSc 647-563-3141 rdoole@ohri.ca
Contact: Adam J Sachs, MD 613-798-5555 ext 14471 asachs@toh.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03100110
Other Study ID Numbers  ICMJE 20170100-01H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ottawa Hospital Research Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ottawa Hospital Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ottawa Hospital Research Institute
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP