Telehealth Implementation of Brain-Computer Interface

Sponsor

Shirley Ryan AbilityLab (Other)

Overall Status

Recruiting

CT.gov ID

NCT05951556

Collaborator

Albany Stratton VA Medical Center (U.S. Fed)

Enrollment

Location

Arm

33.1

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis Stroke	Device: Use of BCI	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Participants will be provided with device; telehealth appts will be utilized to direct setup and usage of the device.Participants will be provided with device; telehealth appts will be utilized to direct setup and usage of the device.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 30, 2021

Anticipated Primary Completion Date :

Jul 5, 2024

Anticipated Study Completion Date :

Jul 5, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: All Participants

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

Device: Use of BCI

Clients will utilize BCI with training to communicate wants and needs

Outcome Measures

Primary Outcome Measures

Log of communication [From date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months]
Logs of any communication will be kept by monitoring number of accurate selections while utilizing the BCI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis leading to severe communication impairment

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ShirleyRyan AbilityLab	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Shirley Ryan AbilityLab
Albany Stratton VA Medical Center

Investigators

Principal Investigator: Colin Franz, MD, SRALAB

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Colin Franz, Attending MD, Principal investigator, Shirley Ryan AbilityLab

ClinicalTrials.gov Identifier:

NCT05951556

Other Study ID Numbers:

ShirleyRyanAbilityLab

First Posted:

Jul 19, 2023

Last Update Posted:

Jul 19, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Colin Franz, Attending MD, Principal investigator, Shirley Ryan AbilityLab

locked in syndrome

Additional relevant MeSH terms:

Motor Neuron Disease

Amyotrophic Lateral Sclerosis

Study Results

No Results Posted as of Jul 19, 2023