An In-home Study of Brain Computer Interfaces

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

An In-home Study of Brain Computer Interfaces

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123200
• Other study ID #: J0002
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: March 14, 2017
• Start date: January 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of BCI Usage by Persons With ALS.	Number of months of BCI usage by each participant.	Monthly measurements for a period of up to 18 months.
Secondary	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.	6 months, 12 months, 18 months

External Links

•   UM-DBI Project