NCT07407725 · Shirley Ryan AbilityLab
Clinical Outcome Assessment for AT & BCI
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations