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NCT07209943

Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro

Not yet recruiting NA Last updated 7 October 2025
What this trial tests

NA trial testing Cognixion + Apple Vision Pro in ALS (Amyotrophic Lateral Sclerosis) in 10 participants. Not yet recruiting.

Timeline
16 October 2025
Primary endpoint
30 April 2026
31 May 2026

Quick facts

Lead sponsorCognixion
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment10
Start date16 October 2025
Primary completion30 April 2026
Estimated completion31 May 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cognixion

Who can join

18 and older, any sex, with ALS (Amyotrophic Lateral Sclerosis) or TBI Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this study is refine the usability of a BCI capable communication platform. The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Each subject will receive an integrated Cognixion + Apple Vision Pro device that includes an augmented reality brain computer interface and associated communication software. The study duration is 3-4 months for each participant. The key questions that will be addressed in this study are: 1. Identify the ability of individuals with target indications to use the integrated Cognixion-Apple Vision Pro system to communicate effectively. 2. Identify the ability of such individuals to learn to use BCI, ET-BCI and other modalities, and to measure their progress over time. 3. Identify the effectiveness of the different forms of input supported by the combined Cognixion-Apple Vision Pro system (BCI, eye-tracking) in allowing such individuals to communicate and have agency. 4. Identify how input such as BCI can be optimized to suit the needs of individuals (e.g., specific frequencies that work best for an individual, SNR with different frequencies, number of targets, length of recording for each frequency) and improve overall usability. 5. Identify the extent to which personalization through a large language model (LLM) affects communication. 6. Identify the appropriate capabilities to enable through an agentic communication interface. Key measures include: ITR - information transfer rate SUS - system usability scale

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for ALS (Amyotrophic Lateral Sclerosis)

Currently open trials in the same condition.

Other Cognixion trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07209943.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing