N/A
Completed N=1
An In-home Study of Brain Computer Interfaces
Source: ClinicalTrials.gov NCT01123200 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Duration of BCI Usage by Persons With ALS. — 5 months
Summary
The investigators are developing a tool to help people who are severely paralyzed. This tool is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic devices.
This study allows a person with ALS to communicate, control their wheelchair tilt and perform other tasks using a BCI, thus increasing their independence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of BCI Usage by Persons With ALS. |
5 | — |
| SECONDARY Changes in Accuracy of BCI for Controlling Devices and Text |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 or older.
- Presently having difficulty communicating or operating the controls for assistive technology or likely to have difficulty in the next six months.
- Able to see the BCI display
- Able to understand and remember instructions concerning participation.
- Live in an environment that can accommodate the wheelchair portable BCI host computer
- Expected to live in the same physical environment for at least 6 months.
- Has family and caregiver(s) who are supportive of participation in this research.
- Has a primary caregiver who is technically capable, willing to learn the setup and operation of the BCI system, and likely to remain with the subject for at least 6 months.
- Has been shown to be able to use a BCI (in an experimental session under another IRB, e.g. HUM 00012968).
- Has a clear understanding of the shortcomings of the present state of BCI technology
Exclusion Criteria
- Open head lesions or a history of problems with skin breakdown on the head that may be aggravated by repeated application of electrodes.
- Inability to communicate well enough to give informed consent.
- History of photo-sensitive epilepsy
- Known significant cognitive deficits
Data sourced from ClinicalTrials.gov (NCT01123200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.