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

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Device: P300 Brain Computer Interface Keyboard

• Registration Number: NCT01119001
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2015-05-27
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-10
• Last Update Submitted: 2015-06-10
• Results First Posted: 2015-06-12
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
P300 Brain Computer Interface for people with ALS	P300 Brain Computer Interface Keyboard	-

Primary Outcome Measures

Name	Time	Method
Accuracy of Typing With a BCI Keyboard by ALS Patients.	3 times over 2-4 weeks	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States