Telehealth Implementation of Brain-Computer Interface

Stroke Clinical Trial

Official title:

Individualizing Home Use of an Electroencephalographic or EEG-based Brain-computer Interface (BCI) Using Telemedicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951556
• Other study ID #: ShirleyRyanAbilityLab
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: July 5, 2024

Study information

• Verified date: July 2023
• Source: Shirley Ryan AbilityLab
• Contact: Edward C Hitchcock, OT/L
• Phone: 312 238 2997
• Email: ehitchcock[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: July 5, 2024
• Est. primary completion date: July 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

Inclusion Criteria:

• Diagnosis leading to severe communication impairment

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Stroke

Intervention

Device:
• Use of BCI
Clients will utilize BCI with training to communicate wants and needs

Locations

Country	Name	City	State
United States	ShirleyRyan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Albany Stratton VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Log of communication	Logs of any communication will be kept by monitoring number of accurate selections while utilizing the BCI.	From date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months