- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01123200
An In-home Study of Brain Computer Interfaces
The investigators are developing a tool to help people who are severely paralyzed. This tool is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic devices.
This study allows a person with ALS to communicate, control their wheelchair tilt and perform other tasks using a BCI, thus increasing their independence.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This small-scale study of the feasibility of a BCI to operate the tilt position of a power wheelchair was also designed to determine the conditions and support structures necessary for use of a BCI in the home. In this study, people with Amyotrophic Lateral Sclerosis (ALS) will have a BCI in their home. They will receive training in order to operate and maintain the BCI. The BCI will allow them to access at least one task of primary interest to them. Task may include communication, computer access, control of assistive technology, or control of wheelchair seat position. Data concerning the use of the BCI will be collected throughout the study. Custom installations will be made for each participant to connect to their wheelchair and provide communication options if needed. Each installation is expected to be a unique prototype because of the differing control requirements for the individual wheelchairs in use by the participants.
We intended to enroll six participants, but were only able to enroll one.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 or older.
- Presently having difficulty communicating or operating the controls for assistive technology or likely to have difficulty in the next six months.
- Able to see the BCI display
- Able to understand and remember instructions concerning participation.
- Live in an environment that can accommodate the wheelchair portable BCI host computer
- Expected to live in the same physical environment for at least 6 months.
- Has family and caregiver(s) who are supportive of participation in this research.
- Has a primary caregiver who is technically capable, willing to learn the setup and operation of the BCI system, and likely to remain with the subject for at least 6 months.
- Has been shown to be able to use a BCI (in an experimental session under another IRB, e.g. HUM 00012968).
- Has a clear understanding of the shortcomings of the present state of BCI technology
Exclusion Criteria:
- Open head lesions or a history of problems with skin breakdown on the head that may be aggravated by repeated application of electrodes.
- Inability to communicate well enough to give informed consent.
- History of photo-sensitive epilepsy
- Known significant cognitive deficits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Brain Computer Interface In-Home Use
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Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of BCI Usage by Persons With ALS.
Time Frame: Monthly measurements for a period of up to 18 months.
|
Number of months of BCI usage by each participant.
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Monthly measurements for a period of up to 18 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Accuracy of BCI for Controlling Devices and Text
Time Frame: 6 months, 12 months, 18 months
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Changes in Accuracy Percentage (i.e., cumulative correct selections per month divided by the cumulative number of intended sections per month).
Looking for trends over each 6 month period.
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6 months, 12 months, 18 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- J0002
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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