An interventional study of Use of BCI in Amyotrophic Lateral Sclerosis and Stroke, sponsored by Shirley Ryan AbilityLab. Recruiting at 1 site in United States. Open to participants aged 16 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Supportive care
Determine if Telehealth intervention can allow/empower a caregiver (who is untrained) to effectively implement and utilize a Brain-Computer Interface for communication with a participant who is "Locked in" following progression of Amyotrophic Lateral Sclerosis and other conditions.
People with Amyotrophic Lateral Sclerosis (ALS) or other conditions such as a pontine stroke may develop a condition called Locked In Syndrome (LIS) where they are unable to use alternative communication strategies such as eyegaze to allow for communication for social needs or instruction to caregivers. Brain-Computer Interface (BCI) devices have been shown in the laboratory to allow participants to effectively communicate needs and engage in social communication. However, translation of this research to the home environment has been limited. In order to be a functional option for people to utilize, BCI needs to be much easier to set up and operate.
This study is designed to determine if telehealth intervention is sufficient to allow an untrained caregiver to set up and maintain a BCI for a person with a long-term communication difficulty given LIS.
Participants will receive a computer and associated hardware to allow for set up of the BCI. Videoconference support will be provided by the research team to allow the client and caregiver to set up the device in their home. Participants will hopefully be able to use the device to generate novel communication related to their care and engage in social needs with caregivers and/or family members. Communication that is generated will be logged and times that the participant is engaged in use of the BCI when not under direct support by the researchers will also be monitored.
The hypothesis is that telehealth support will be sufficient to allow for setting up the computer. If this is true, this will make it much easier for a client to engage in use of a BCI to allow for that communication versus the current need of traveling to a clinic or other specialized setting.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's planned enrollment of 7 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →Shirley Ryan AbilityLab is the lead sponsor of 177 studies on the registry; 43 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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All Participants will receive trial device and will be trained (via Telehealth) in its use.
Device: Use of BCI
Clients will utilize BCI with training to communicate wants and needs
Log of communication
Logs of any communication will be kept by monitoring number of accurate selections while utilizing the BCI.
Time frame: From date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months
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