NeuroCognitive Communicator: Safety Study (NCC-1701)
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|ClinicalTrials.gov Identifier: NCT03100110|
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : August 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Motor Neuron Disease, Amyotrophic Lateral Sclerosis Tetraplegia||Device: NeuroCognitive Communicator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.|
|Actual Study Start Date :||May 13, 2019|
|Estimated Primary Completion Date :||April 15, 2024|
|Estimated Study Completion Date :||April 15, 2024|
|Experimental: NeuroCognitive Communicator||
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100110
|Contact: Robert Doole, MScfirstname.lastname@example.org|
|Contact: Adam J Sachs, MD||613-798-5555 ext email@example.com|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Contact: Robert Doole, MSc 6475633141 firstname.lastname@example.org|