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An In-home Study of Brain Computer Interfaces

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brain Computer Interface for Wheelchair Tilt Control

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Brain Computer Interface In-Home Use

Arm Description

Outcomes

Primary Outcome Measures

Duration of BCI Usage by Persons With ALS.

Number of months of BCI usage by each participant.

Secondary Outcome Measures

Changes in Accuracy of BCI for Controlling Devices and Text

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.

Full Information

NCT ID

NCT01123200

First Posted

May 4, 2010

Last Updated

March 14, 2017

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT01123200

Brief Title

An In-home Study of Brain Computer Interfaces

Official Title

An In-home Study of Brain Computer Interfaces

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brain Computer Interface In-Home Use

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Brain Computer Interface for Wheelchair Tilt Control

Intervention Description

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.

Primary Outcome Measure Information:

Title

Duration of BCI Usage by Persons With ALS.

Description

Number of months of BCI usage by each participant.

Time Frame

Monthly measurements for a period of up to 18 months.

Secondary Outcome Measure Information:

Title

Changes in Accuracy of BCI for Controlling Devices and Text

Description

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.

Time Frame

6 months, 12 months, 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane Huggins, PhD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.umich.edu/~umdbi/

Description

UM-DBI Project

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An In-home Study of Brain Computer Interfaces

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