Clinical Outcome Assessment for AT & BCI

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: ALS (Amyotrophic Lateral Sclerosis); Spinal Cord Injury

Treatments: Device: Eye Tracker; Device: Non-invasive electroencephalogram (EEG) Headset; Device: Mouth Operated Joystick; Device: Personal Assistive Technology; Device: Implantable Brain-Computer-Interface

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07407725

STU00224714

Details and patient eligibility

About

Many individuals with severe motor impairments rely on Assistive Technologies (ATs) or Brain-Computer Interfaces (BCIs) to interact with digital devices such as their computers. Clinicians and researchers currently lack a common framework to objectively quantify how much a given AT or BCI improves real-world function or to compare across tools. This project seeks to address this gap by developing a standardized method to objectively assess or compare the functional benefit of these tools on digital independence, i.e., the ability to independently operate computers, phones, and other digital systems, by creating a unique Digital Assessment Interface (DAI).

This assessment will be a simulation of online and digital activities that prior work has determined is important to functional daily living in the digital domain. Participants will complete this assessment with various ATs and BCIs, and these scores will be used to create an index, which will be comprised of performance outcomes, clinician-reported outcomes, and patient-reported outcomes.

The tool aims to quantify and compare digital task performance across devices and user populations. The primary objective of this study is to develop an index. The index will quantify functional performance of individuals using various ATs and BCIs. The secondary objectives are to extensively evaluate the psychometric properties of the index, such as the validity, responsiveness, reliability, and floor/ceiling effects both globally and across different devices and impairment levels, ensuring that it can reliably measure the impact of an AT or BCI on a user's ability to independently operate digital systems; and to characterize the familiarization and use of specific BCI and AT systems with reference to a normative healthy control population.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Enrollment will involve three different cohorts, namely a cohort of healthy participant, a cohort of ALS/SCI participant who underwent the implant of an invasive BCI device, and a cohort of ALS/SCI participants without any implanted BCI device.

Below are listed the inclusion and exclusion criteria for each diagnostic group.

Spinal Cord Injury (SCI):

Inclusion Criteria:

• Age at or above 18 years old;
• Diagnosis of spinal cord injury, at the level of T1 or above levels (between C1 and T1);
• Ability to communicate independently or with a support device, or with a legal representative;
• Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.

Exclusion Criteria:

• Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.

Amyotrophic Lateral Sclerosis (ALS):

Inclusion criteria:

• Age at or above 18 years old;
• Diagnosis of amyotrophic lateral sclerosis;
• Ability to communicate independently, with a support device, or with a legal representative;
• Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.

Exclusion criteria:

● Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.

Healthy Controls:

Inclusion criteria:

• Age at or above 18 years old;
• No history of neurological or psychiatric disorders;
• Ability to provide written informed consent;
• Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.

Exclusion criteria:

• Participation in another trial that would conflict with the current study or clinical endpoint interference may occur;
• Cognitive, visual, or auditory deficits that would interfere with study participation;
• Current or prior diagnosis or condition that could confound study assessments.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 1 patient group

AT/BCI User

Experimental group

Description:

Participants in this arm will undergo training and a digital assessment using 3 assistive technologies (eye tracker, mouth-operated joystick, non-invasive electroencephalogram (EEG) headset), brain-computer-interfaces, and applicable personal ATs. Participants will experience each of these devices in a randomized order. Participants in this arm will include individuals with a diagnosis of amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), or healthy individuals.

Treatment:

Device: Personal Assistive Technology

Device: Implantable Brain-Computer-Interface

Device: Mouth Operated Joystick

Device: Non-invasive electroencephalogram (EEG) Headset

Device: Eye Tracker