Telehealth Implementation of Brain-Computer Interface

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke, Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Device: Use of BCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis leading to severe communication impairment Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be provided with device; telehealth appts will be utilized to direct setup and usage of the device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants<br>All Participants will receive trial device and will be trained (via Telehealth) in its use. | Device: Use of BCI<br>* Clients will utilize BCI with training to communicate wants and needs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locked in syndrome