Amyotrophic Lateral SclerosisNCT01123200
An In-home Study of Brain Computer Interfaces
A study of Amyotrophic Lateral Sclerosis, run by University of Michigan at 1 site in United States.
Trial summary
The investigators are developing a tool to help people who are severely paralyzed. This tool is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Presently having difficulty communicating or operating the controls for assistive technology or likely to have difficulty in the next six months.
- Able to see the BCI display
- Able to understand and remember instructions concerning participation.
- Live in an environment that can accommodate the wheelchair portable BCI host computer
- Expected to live in the same physical environment for at least 6 months.
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- Has family and caregiver(s) who are supportive of participation in this research.
- Has a primary caregiver who is technically capable, willing to learn the setup and operation of the BCI system, and likely to remain with the subject for at least 6 months.
- Has been shown to be able to use a BCI (in an experimental session under another IRB, e.g. HUM 00012968).
- Has a clear understanding of the shortcomings of the present state of BCI technology
Who cannot join
- Open head lesions or a history of problems with skin breakdown on the head that may be aggravated by repeated application of electrodes.
- Inability to communicate well enough to give informed consent.
- History of photo-sensitive epilepsy
- Known significant cognitive deficits
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are developing a tool to help people who are severely paralyzed. This tool is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic devices.
This study allows a person with ALS to communicate, control their wheelchair tilt and perform other tasks using a BCI, thus increasing their independence.
Read the detailed description
This small-scale study of the feasibility of a BCI to operate the tilt position of a power wheelchair was also designed to determine the conditions and support structures necessary for use of a BCI in the home. In this study, people with Amyotrophic Lateral Sclerosis (ALS) will have a BCI in their home. They will receive training in order to operate and maintain the BCI. The BCI will allow them to access at least one task of primary interest to them. Task may include communication, computer access, control of assistive technology, or control of wheelchair seat position. Data concerning the use of the BCI will be collected throughout the study. Custom installations will be made for each participant to connect to their wheelchair and provide communication options if needed. Each installation is expected to be a unique prototype because of the differing control requirements for the individual wheelchairs in use by the participants.
We intended to enroll six participants, but were only able to enroll one.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Brain Computer Interface for Wheelchair Tilt Control
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Computer Interface for Wheelchair Tilt ControlDevice
Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Brain Computer Interface In-Home Use | Other | Not described Receives: Device: Brain Computer Interface for Wheelchair Tilt Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of BCI Usage by Persons With ALS.
Number of months of BCI usage by each participant.
Measured: Monthly measurements for a period of up to 18 months.
Secondary outcomes (1)
Changes in Accuracy of BCI for Controlling Devices and Text
Changes in Accuracy Percentage (i.e., cumulative correct selections per month divided by the cumulative number of intended sections per month). Looking for trends over each 6 month period.
Measured: 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Huggins, PhD, University of Michigan
- Investigators
- Jane Huggins, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123200
- Sponsor's protocol ID
- J0002
- Status last verified
- Mar 2017
- First submitted
- 4 May 2010
- Last updated
- 15 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-home Study of Brain Computer Interfaces
- ClinicalTrials.gov ID
- NCT01123200
- Acronym / sponsor ID
- J0002
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Posted 15 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are developing a tool to help people who are severely paralyzed. This tool is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic devices.
This study allows a person with ALS to communicate, control their wheelchair tilt and perform other tasks using a BCI, thus increasing their independence.
Detailed description
This small-scale study of the feasibility of a BCI to operate the tilt position of a power wheelchair was also designed to determine the conditions and support structures necessary for use of a BCI in the home. In this study, people with Amyotrophic Lateral Sclerosis (ALS) will have a BCI in their home. They will receive training in order to operate and maintain the BCI. The BCI will allow them to access at least one task of primary interest to them. Task may include communication, computer access, control of assistive technology, or control of wheelchair seat position. Data concerning the use of the BCI will be collected throughout the study. Custom installations will be made for each participant to connect to their wheelchair and provide communication options if needed. Each installation is expected to be a unique prototype because of the differing control requirements for the individual wheelchairs in use by the participants.
We intended to enroll six participants, but were only able to enroll one.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Computer Interface In-Home Use | Other | Device: Brain Computer Interface for Wheelchair Tilt Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 or older.
- Presently having difficulty communicating or operating the controls for assistive technology or likely to have difficulty in the next six months.
- Able to see the BCI display
- Able to understand and remember instructions concerning participation.
- Live in an environment that can accommodate the wheelchair portable BCI host computer
Key exclusion criteria (4 listed)
- Open head lesions or a history of problems with skin breakdown on the head that may be aggravated by repeated application of electrodes.
- Inability to communicate well enough to give informed consent.
- History of photo-sensitive epilepsy
- Known significant cognitive deficits
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 |
|---|---|---|
| Brain Computer Interface for Wheelchair Tilt ControlPatients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions. | Device | Brain Computer Interface In-Home Use |
Primary outcome
Duration of BCI Usage by Persons With ALS.
Time frame: Monthly measurements for a period of up to 18 months.
Number of months of BCI usage by each participant.
1 secondary outcome
Changes in Accuracy of BCI for Controlling Devices and Text
Time frame: 6 months, 12 months, 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jane Huggins, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Amyotrophic Lateral Sclerosis, run by University of Michigan 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 10 inclusion and 4 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: finished, as of the sponsor's last update on 15 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of BCI Usage by Persons With ALS. (time frame: Monthly measurements for a period of up to 18 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 15 Mar 2017.