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The goal of this study is refine the usability of a BCI based communication platform.
The study will take place in the greater Los Angeles area and will enroll up to 10 participants with late stage ALS. Each subject will receive a Cognixion Axon-R augmented reality brain computer interface and associated communication software. The study duration is 3 months for each participant.
The key questions that will be addressed in this study are:
Key measures include:
ITR - information transfer rate SUS - system usability scale
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usability Study | Experimental | Participants will utilize the Cognixion Axon-R device and associated communication software for practice and communication tasks as prescribed by the study administrator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognixion ONE | Device | A wearable augmented reality brain computer interface with self contained computer and software to enable communication using the device input and output capabilities. |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Score | A score ranging from 0 to 100 that captures the usability the device. This is an essential characteristic of a device feasibility study. | 3 months from training and setup of device. |
| Information Transfer Rate (ITR) | The rate, in bits per minute, of information transfer for each of the device modalities. ITR is measured using a standardized selection procedure. | 3 months from training and setup of device. |
| Measure | Description | Time Frame |
|---|---|---|
| Words per Minute (WPM) | WPM is the number of words that a participant can speak in one minute. This statistic is calculated by counting the total time from partner utterance until a response is spoken by the participant. | 3 months from training and setup of device. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Principal Investigator | Contact | 8053200774 | chris@cognixion.com | |
| Cole Study Coordinator | Contact | 214-907-6399 | cole@cognixion.com |
| Name | Affiliation | Role |
|---|---|---|
| Chris Principal Investigator | Cognixion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognixion | Recruiting | Santa Barbara | California | 93101-1665 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590 | ||
| 29676287 | Background | Kellmeyer P, Grosse-Wentrup M, Schulze-Bonhage A, Ziemann U, Ball T. Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing. J Neural Eng. 2018 Aug;15(4):041003. doi: 10.1088/1741-2552/aabfa5. Epub 2018 Apr 20. | |
| 29950436 |
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Usability insights related to this use case on this type of device will be shared with other accessibility and BCI researchers at conference events and through publications.
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| Background |
| Wolpaw JR, Bedlack RS, Reda DJ, Ringer RJ, Banks PG, Vaughan TM, Heckman SM, McCane LM, Carmack CS, Winden S, McFarland DJ, Sellers EW, Shi H, Paine T, Higgins DS, Lo AC, Patwa HS, Hill KJ, Huang GD, Ruff RL. Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. Neurology. 2018 Jul 17;91(3):e258-e267. doi: 10.1212/WNL.0000000000005812. Epub 2018 Jun 27. |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |