- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01123148
A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
June 20, 2016 updated by: Jane Huggins, PhD, University of Michigan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Tilt testing
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 1-2 hour sessions over 2-4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
May 4, 2010
First Submitted That Met QC Criteria
May 11, 2010
First Posted (Estimate)
May 14, 2010
Study Record Updates
Last Update Posted (Estimate)
August 1, 2016
Last Update Submitted That Met QC Criteria
June 20, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M0001
- R21HD054913 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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