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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01119001
First Posted: May 7, 2010
Last Update Posted: June 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan
  Purpose
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.

Condition Intervention
Amyotrophic Lateral Sclerosis Device: P300 Brain Computer Interface Keyboard

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A P300 Brain Computer Interface Keyboard to Control Assistive Technology for People With Amyotrophic Lateral Sclerosis

Resource links provided by NLM:


Further study details as provided by Jane Huggins, PhD, University of Michigan:

Primary Outcome Measures:
  • Accuracy of Typing With a BCI Keyboard by ALS Patients. [ Time Frame: 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.



Enrollment: 13
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P300 Brain Computer Interface for people with ALS 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.
Other Name: Electrode cap made by Electro-cap International.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119001


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
U.S. Department of Education
Investigators
Principal Investigator: Jane Huggins, PhD University of Michigan
  More Information

Additional Information:
Publications:
Responsible Party: Jane Huggins, PhD, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01119001     History of Changes
Other Study ID Numbers: H0004
First Submitted: May 5, 2010
First Posted: May 7, 2010
Results First Submitted: May 27, 2015
Results First Posted: June 12, 2015
Last Update Posted: June 12, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases