Amyotrophic Lateral SclerosisNCT05951556
Telehealth Implementation of Brain-Computer Interface
A study testing Use of BCI in people with Amyotrophic Lateral Sclerosis and Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Stroke
- What is being tested?
- Use of BCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 5 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis leading to severe communication impairment
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
ShirleyRyan AbilityLab
Chicago, Illinois, 60611
Edward C Hitchcock, OT/L, 312-238-2997, ehitchcock@sralab.org
About this study
Official title: Individualizing Home Use of an Electroencephalographic or EEG-based Brain-computer Interface (BCI) Using Telemedicine
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.
Read the 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
- Being tested
- Use of BCI
- Keywords
- locked in syndrome
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Stroke, Locked-In Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of BCIDevice
Clients will utilize BCI with training to communicate wants and needs
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | All Participants will receive trial device and will be trained (via Telehealth) in its use. Receives: Device: Use of BCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log of communication
Logs of any communication will be kept by monitoring number of accurate selections while utilizing the BCI.
Measured: From date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start30 Sep 2021
- Primary completion5 Jul 2024 (estimated)
- Study completion5 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Albany Stratton VA Medical Center
- Responsible party
- Principal investigator, Colin Franz, Shirley Ryan AbilityLab
- Investigators
- Colin Franz, MD, Principal investigator, SRALAB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951556
- Sponsor's protocol ID
- ShirleyRyanAbilityLab
- Status last verified
- Jul 2023
- First submitted
- 4 May 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing Home Use of an Electroencephalographic or EEG-based Brain-computer Interface (BCI) Using Telemedicine
- ClinicalTrials.gov ID
- NCT05951556
- Acronym / sponsor ID
- ShirleyRyanAbilityLab
- Conditions
- Amyotrophic Lateral Sclerosis, Stroke
- Keywords
- locked in syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Albany Stratton VA Medical Center
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 5 Jul 2024 (estimated)
- Study completion
- 5 Jul 2024 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be provided with device; telehealth appts will be utilized to direct setup and usage of the device.
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Device: Use of BCIAll Participants will receive trial device and will be trained (via Telehealth) in its use. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis leading to severe communication impairment
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of BCIClients will utilize BCI with training to communicate wants and needs | Device | All Participants |
Primary outcome
Log of communication
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Franz, MD principal investigator
SRALAB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of BCI in people with Amyotrophic Lateral Sclerosis and Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward C Hitchcock, OT/L (312 238 2997, ehitchcock@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Log of communication (time frame: From date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.