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Telehealth Implementation of Brain-Computer Interface

Primary Purpose

Amyotrophic Lateral Sclerosis, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of BCI
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring locked in syndrome

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ShirleyRyan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

All Participants will receive trial device and will be trained (via Telehealth) in its use.

Outcomes

Primary Outcome Measures

Log of communication
Logs of any communication will be kept by monitoring number of accurate selections while utilizing the BCI.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2022
Last Updated
July 18, 2023
Sponsor
Shirley Ryan AbilityLab
Collaborators
Albany Stratton VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05951556
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
July 5, 2024 (Anticipated)
Study Completion Date
July 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
Albany Stratton VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis, Stroke
Keywords
locked in syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Arm Description
All Participants will receive trial device and will be trained (via Telehealth) in its use.
Intervention Type
Device
Intervention Name(s)
Use of BCI
Intervention Description
Clients will utilize BCI with training to communicate wants and needs
Primary Outcome Measure Information:
Title
Log of communication
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis leading to severe communication impairment Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward C Hitchcock, OT/L
Phone
312 238 2997
Email
ehitchcock@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Franz, MD
Organizational Affiliation
SRALAB
Official's Role
Principal Investigator
Facility Information:
Facility Name
ShirleyRyan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward C Hitchcock, OT/L
Phone
312-238-2997
Email
ehitchcock@sralab.org

12. IPD Sharing Statement

Learn more about this trial

Telehealth Implementation of Brain-Computer Interface

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