Telehealth Implementation of Brain-Computer Interface

NCT ID: NCT05951556

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2024-07-05

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.

Conditions

Amyotrophic Lateral Sclerosis; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

All Participants

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

Group Type: EXPERIMENTAL

Use of BCI

Intervention Type: DEVICE

Clients will utilize BCI with training to communicate wants and needs

Interventions

Use of BCI

Clients will utilize BCI with training to communicate wants and needs

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis leading to severe communication impairment

Exclusion Criteria

-

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albany Stratton VA Medical Center

FED

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Colin Franz

Attending MD, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colin Franz, MD

Role: PRINCIPAL_INVESTIGATOR

SRALAB

Locations

ShirleyRyan AbilityLab

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Edward C Hitchcock, OT/L

Role: CONTACT

ehitchcock@sralab.org

312 238 2997

Facility Contacts

Edward C Hitchcock, OT/L

Role: primary

ehitchcock@sralab.org

312-238-2997

Other Identifiers

ShirleyRyanAbilityLab

Identifier Type: -

Identifier Source: org_study_id