A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis

June 10, 2015 updated by: Jane Huggins, PhD, University of Michigan

A P300 Brain Computer Interface Keyboard to Control Assistive Technology for People With Amyotrophic Lateral Sclerosis

People with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer interface (BCI) keyboard to type in assistive technology devices. The results of this study will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older.
  • Diagnosed with cerebral palsy, spinal cord injury, neuromuscular disease, or ALS that results in impaired hand and arm function making it difficult to manipulate objects (if at all) and requires help to prepare or modify activities
  • Able to see the BCI display
  • Able to give informed consent
  • Able to understand and remember instructions concerning participation
  • Able to communicate effectively at least with familiar conversation partners

Exclusion Criteria:

  • Are unable to give informed consent.
  • Are currently experiencing open head sores
  • Have a history of photo-sensitive epilepsy
  • Have a history of cognitive deficits requiring accommodation or special education services
  • Are unable to sit without moving the head and neck for at least 15 minutes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P300 Brain Computer Interface for people with ALS
Device: P300 Brain Computer Interface Keyboard
Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
Other Names:
  • Electrode cap made by Electro-cap International.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Typing With a BCI Keyboard by ALS Patients.
Time Frame: 3 times over 2-4 weeks

Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.

Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis.
3 times over 2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

U.S. Department of Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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