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

NCT01119001 | Completed Results

• 1 other identifier: H0004
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

P300 Brain Computer Interface for people with ALS

EXPERIMENTAL

Device: P300 Brain Computer Interface Keyboard

Interventions

P300 Brain Computer Interface Keyboard DEVICE

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.

Also known as: Electrode cap made by Electro-cap International.

P300 Brain Computer Interface for people with ALS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• U.S. Department of Education: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related 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.

  PMID: 23590556 RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Jane Huggins
• Organization: University of Michigan

janeh@umich.edu

734-936-7177

Study Officials

• Jane Huggins, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 12, 2015
• Results First Posted: June 12, 2015

Record last verified: 2015-06

Locations

US (1)