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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 data collection sessions over 12 weeks (1 session/week) to assess change
Awards & highlights
BCI-FIT Trial 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.Check my eligibility
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.See study design
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.
BCI-FIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can select letters or icons to communicate despite my severe speech and physical impairments.
Select...
I can read and communicate in English, even with speech or physical challenges.
BCI-FIT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Information transfer rate
Typing Accuracy
Typing Speed
+1 moreBCI-FIT 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.
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
7,385,752 Total Patients Enrolled
Melanie Fried-Oken, PhDPrincipal InvestigatorOregon Health and Science University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- "Controls" typically refers to a group of participants in a study who do not receive the treatment being tested, serving as a comparison for the group receiving the treatment.You have severe difficulty speaking or moving, or have certain types of implanted medical devices.People with severe difficulty speaking or moving, who may be at risk of skin problems from touching the study equipment.I can select and copy letters, words, or icons well enough to communicate.You have severe difficulty speaking or moving, but you are expected to live for more than 6 months.I have a severe condition affecting my speech and movement.I have been hospitalized multiple times in the last 6 weeks due to unstable health.I am an adult between 18-89 with severe speech and physical impairments.I have a condition like muscular dystrophy, ALS, or Parkinson's that affects my brain or muscles.I live within 2 hours of OHSU or can travel there.Despite my severe speech and physical impairments, I can attend study visits for 1-3 hours.You are expected to live for at least 6 more months.I can attend study visits that last between 1 to 3 hours.I can attend study visits that last 1-3 hours.I can select letters or icons to communicate despite my severe speech and physical impairments.I have a condition that causes seizures triggered by lights.I can read and communicate in English, even with speech or physical challenges.
Research Study Groups:
This trial has the following groups:- Group 1: Language modeling
- Group 2: Active querying techniques
- Group 3: BCI-FIT multi-modal configuration
- Group 4: Adaptive signal modeling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment permit individuals above thirty years old to participate?
"This research study mandates that all participants are between 18 and 89 years old. Separately, there are 134 studies for minors and 995 for those over 65."
Answered by AI
Who is most suited to participate in this medical experiment?
"This clinical trial is recruiting a cohort of 60 adults aged between 18 and 89 to study multiple system atrophy. Qualifying patients must be able to communicate in English, dedicate 1-3 hours for each visit with the research team, have been diagnosed with certain degenerative or neurodevelopmental conditions (e.g., Duchenne muscular dystrophy, Rett Syndrome etc.), live within 2 hour drive from OHSU or agree to travel there, and possess sufficient visuospatial skills needed to select letters/words/icons as part of their participation."
Answered by AI
Is the enrollment process for this trial still open?
"According to clinicaltrials.gov, this research endeavour remains in its participant recruitment phase. The trial was first declared on July 15th 2022 and has received revisions as recently as September 7th of the same year."
Answered by AI
How many individuals are currently being recruited for this experiment?
"Affirmative. As per the information found on clinicaltrials.gov, this research study is actively enrolling individuals with its initial post marked July 15th 2022 and most recent update made September 7th 2022. This trial requires 60 participants to be recruited from 1 site."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Oregon Health & Science University
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
Recent research and studies
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