A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis
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ClinicalTrials.gov Identifier: NCT01119001 |
Recruitment Status :
Completed
First Posted : May 7, 2010
Results First Posted : June 12, 2015
Last Update Posted : June 12, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Device: P300 Brain Computer Interface Keyboard | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | N/A |
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 |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
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. |
- 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.

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

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
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Jane Huggins, PhD | University of Michigan |
Publications of Results:
Responsible Party: | Jane Huggins, PhD, Research Assistant Professor, University of Michigan |
ClinicalTrials.gov Identifier: | NCT01119001 |
Other Study ID Numbers: |
H0004 |
First Posted: | May 7, 2010 Key Record Dates |
Results First Posted: | June 12, 2015 |
Last Update Posted: | June 12, 2015 |
Last Verified: | June 2015 |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |