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A P300 Brain Computer Interface to Operate Power Wheelchair Tilt

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ClinicalTrials.gov Identifier: NCT01123148
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : August 1, 2016
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Amyotrophic Lateral Sclerosis Device: Using a BCI to control wheelchair tilt Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
Study Start Date : January 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010


Arm Intervention/treatment
Tilt testing 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.




Primary Outcome Measures :
  1. The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair. [ Time Frame: 3 1-2 hour sessions over 2-4 weeks ]
    Subjects will participate in 3 sessions. During each session each subject will copy a "word" in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT01123148


Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Jane Huggins, PhD University of Michigan

Additional Information:
Responsible Party: Jane Huggins, PhD, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01123148     History of Changes
Other Study ID Numbers: M0001
R21HD054913 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2010    Key Record Dates
Results First Posted: August 1, 2016
Last Update Posted: August 1, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jane Huggins, PhD, University of Michigan:
Brain computer interface
wheelchair control

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