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Brain Computer Interface

BCI-FIT for ALS (BCI-FIT Trial)

N/A

Recruiting

Led By Melanie Fried-Oken, PhD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with severe speech and physical impairment: Adequate visuospatial skills to select letters, words or icons to copy or generate basic messages

Participants with severe speech and physical impairment: Able to read and communicate in English with speech or AAC device

Must not have

Participants with severe speech and physical impairment: Unstable medical conditions (fluctuating health status resulting in multiple hospitalizations within a 6 week interval)

Participants with severe speech and physical impairment: Photosensitive seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 data collection sessions over 12 weeks (1 session/week) to assess change

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new brain-computer interface (BCI) that does not require surgery for people with severe speech and physical impairments. The goal is to improve communication for people with these impairments.

Who is the study for?

This trial is for adults aged 18-89 with severe speech and physical impairments due to conditions like ALS, muscular dystrophy, or brainstem stroke. They must be able to communicate in English and participate in study visits lasting up to 3 hours. Life expectancy should be over 6 months. Excluded are those who can't tolerate weekly visits, have skin risks from hardware contact, unstable medical conditions, certain implants, or photosensitive seizures.

What is being tested?

The BCI-FIT toolkit is being tested which includes adaptive signal modeling and active querying techniques for improving communication through brain-computer interfaces (BCI). It aims to optimize typing speed and accuracy for people with severe speech and physical impairments by using multi-modal signals.

What are the potential side effects?

Since this trial involves non-invasive technology rather than medication, traditional side effects are not a concern. However, participants may experience fatigue during long sessions or discomfort from the equipment used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can select letters or icons to communicate despite my severe speech and physical impairments.

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I can read and communicate in English, even with speech or physical challenges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been hospitalized multiple times in the last 6 weeks due to unstable health.

Select...

I have a condition that causes seizures triggered by lights.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 data collection sessions over 12 weeks (1 session/week) to assess change

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 data collection sessions over 12 weeks (1 session/week) to assess change

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 data collection sessions over 12 weeks (1 session/week) to assess change for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Information transfer rate

Typing Accuracy

Typing Speed

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Language modelingExperimental Treatment1 Intervention

For this single case research design with alternating treatments, 5 control volunteers and 5 participants with severe speech and physical impairment, each with a control partner for partner input will complete a story retell task with BCI-FIT language modeling features on and with BCI-FIT language modeling features off. Outcome measures are information transfer rate and user experience.

Group II: BCI-FIT multi-modal configurationExperimental Treatment1 Intervention

For this single case research design with alternating treatments without baseline, 5 participants with severe speech and physical impairment will complete copy spelling tasks with a standard P300 matrix speller layout and with the multi-modal configurations optimized from the BCI-FIT algorithms. Outcome measures are typing accuracy, typing speed and user experience.

Group III: Adaptive signal modelingExperimental Treatment1 Intervention

For this single case research design with alternating treatments without baseline, 5 participants with severe speech and physical impairment will complete copy spelling tasks with 3 signal adaptive modeling configurations. Outcome measures are typing accuracy, typing speed and user experience.

Group IV: Active querying techniquesExperimental Treatment1 Intervention

For this single case research design with alternating treatments without baseline, 5 control volunteers and 5 participants with severe speech and physical impairment who have AUC scores between 70-80% will complete copy spelling tasks with BCI-FIT active querying technique on and with BCI-FIT active querying technique off. Outcome measures are typing accuracy, typing speed and user experience.

0 / 4Eligibility criteria met