Telehealth Implementation of Brain-Computer Interface | NCT05951556

Studies
Telehealth Implementation of Brain-Computer Interface

NCT05951556

Sponsor

Shirley Ryan AbilityLab

Status

Unknown status

Last Update Posted

Jul 19, 2023Actual

Enrollment

7Estimated

Phase

Not Applicable

Conditions

Amyotrophic Lateral Sclerosis
Stroke

Interventions

Use of BCI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2021Actual

Primary Completion Date

Jul 5, 2024Estimated

Completion Date

Jul 5, 2024Estimated

First Submitted Date

May 4, 2022

First Submission Date that Met QC Criteria

Jul 18, 2023

First Posted Date

Jul 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2023

Last Update Posted Date

Jul 19, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Colin Franz, Attending MD, Principal investigator, Shirley Ryan AbilityLabPrincipal Investigator

Lead Sponsor

Shirley Ryan AbilityLabOTHER

Collaborators

Name	Class
Albany Stratton VA Medical Center	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All Participants	Experimental	All Participants will receive trial device and will be trained (via Telehealth) in its use.	Device: Use of BCI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Use of BCI	Device	Clients will utilize BCI with training to communicate wants and needs	All Participants

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis leading to severe communication impairment

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Edward C Hitchcock, OT/L	Contact	312 238 2997		ehitchcock@sralab.org

Overall Officials

Name	Affiliation	Role
Colin Franz, MD	SRALAB	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ShirleyRyan AbilityLab	Recruiting	Chicago	Illinois	60611	United States

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis
D020521	Stroke
D000080422	Locked-In Syndrome

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided