Clinical trial NCT05951556: Telehealth Implementation of Brain-Computer Interface
Official title: Individualizing Home Use of an Electroencephalographic or EEG-based Brain-computer Interface (BCI) Using Telemedicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Stroke
Keywords: locked in syndrome
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Albany Stratton VA Medical Center
First posted: 2023-07-19
Enrollment: 7
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be provided with device; telehealth appts will be utilized to direct setup and usage of the device.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis leading to severe communication impairment

Exclusion Criteria:

-

Primary outcomes:
measure: Log of communication
timeFrame: From date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: ShirleyRyan AbilityLab
state: Illinois
Study officials:
affiliation: SRALAB
name: Colin Franz, MD
role: PRINCIPAL_INVESTIGATOR
References: