A P300 Brain Computer Interface to Operate Power Wheelchair Tilt

Healthy Clinical Trial

Official title:

A P300 Brain Computer Interface to Operate Power Wheelchair Tilt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123148
• Other study ID #: M0001
• Secondary ID: R21HD054913
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: June 16, 2014
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: June 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators want to develop a brain-computer interface (BCI) that will eventually allow people who are completely paralyzed to independently control the tilt feature on their power wheelchairs. This study will allow healthy volunteers to test the feasibility and accuracy of controlling a BCI using only their brain signals while seated in a tilting wheelchair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older.

• Able to read text on a computer screen

• Able to understand and remember instructions concerning participation.

Exclusion Criteria:

• Unable give informed consent.

• Unable to understand and follow instructions.

• Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.

• Known to have photosensitive epilepsy.

• Open head lesions or sores.

Study Design

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Healthy

Intervention

Device:
• Using a BCI to control wheelchair tilt
Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of BCI typing while tilting in a power wheelchair and while sitting still in a power wheelchair.	Subjects will participate in 3 sessions. During each session each subject will copy a word by typing using only brainwaves. The accuracy of the subject's copy spelling of the designated word will be measured for each session. Changes in the wheelchair's position may affect spelling accuracy	3 1-2 hour sessions over 2-4 weeks	No

External Links

•   University of Michigan Direct Brain Interface Project