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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

Tracking Information
First Submitted Date  ICMJE May 4, 2010
First Posted Date  ICMJE May 14, 2010
Results First Submitted Date  ICMJE January 12, 2017
Results First Posted Date  ICMJE March 15, 2017
Last Update Posted Date March 15, 2017
Study Start Date  ICMJE January 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2010)
Duration of BCI usage by patients with ALS. [ Time Frame: On average, 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An In-home Study of Brain Computer Interfaces
Official Title  ICMJE An In-home Study of Brain Computer Interfaces
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE Brain Computer Interface In-Home Use
Intervention: Device: Brain Computer Interface for Wheelchair Tilt Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2016)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2010)
6
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01123200
Other Study ID Numbers  ICMJE J0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jane Huggins, PhD, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jane Huggins, PhD University of Michigan
PRS Account University of Michigan
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP