A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

A P300 Brain Computer Interface Keyboard to Control Assistive Technology for People With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119001
• Other study ID #: H0004
• Status: Completed
• Phase: N/A
• First received: May 5, 2010
• Last updated: June 10, 2015
• Start date: February 2010
• Est. completion date: August 2010

Study information

• Verified date: June 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

People with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer interface (BCI) keyboard to type in assistive technology devices. The results of this study will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older.

• Diagnosed with cerebral palsy, spinal cord injury, neuromuscular disease, or ALS that results in impaired hand and arm function making it difficult to manipulate objects (if at all) and requires help to prepare or modify activities

• Able to see the BCI display

• Able to give informed consent

• Able to understand and remember instructions concerning participation

• Able to communicate effectively at least with familiar conversation partners

Exclusion Criteria:

• Are unable to give informed consent.

• Are currently experiencing open head sores

• Have a history of photo-sensitive epilepsy

• Have a history of cognitive deficits requiring accommodation or special education services

• Are unable to sit without moving the head and neck for at least 15 minutes

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Device:
• P300 Brain Computer Interface Keyboard
Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	U.S. Department of Education

Country where clinical trial is conducted

United States, 

References & Publications (1)

Thompson DE, Gruis KL, Huggins JE. A plug-and-play brain-computer interface to operate commercial assistive technology. Disabil Rehabil Assist Technol. 2014 Mar;9(2):144-50. doi: 10.3109/17483107.2013.785036. Epub 2013 Apr 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Typing With a BCI Keyboard by ALS Patients.	Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.; Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis.	3 times over 2-4 weeks	No

External Links

•   University of Michigan Direct Brain Interface Project