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An In-home Study of Brain Computer Interfaces

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01123200
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: Brain Computer Interface for Wheelchair Tilt Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An In-home Study of Brain Computer Interfaces
Study Start Date : January 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Brain Computer Interface In-Home Use Device: Brain Computer Interface for Wheelchair Tilt Control
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in Accuracy of BCI for Controlling Devices and Text [ Time Frame: 6 months, 12 months, 18 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123200


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Jane Huggins, PhD University of Michigan
More Information
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Additional Information:

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Responsible Party: Jane Huggins, PhD, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01123200    
Other Study ID Numbers: J0002
First Posted: May 14, 2010    Key Record Dates
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases