Amyotrophic Lateral SclerosisBCINCT00718458
EEG-Based Brain-Computer Interface Project for Individuals With Amyotrophic Lateral Sclerosis (ALS)
An observational study of Amyotrophic Lateral Sclerosis and Neurodegenerative Disease, run by Drexel University College of Medicine at 1 site in United States.
Trial summary
Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular condition characterized by weakness, muscle wasting, fasciculations and increased reflexes. Depending on the site of onset, individuals with ALS progressively lose control of their skeletal muscles; bulbar or the extremities. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Neurodegenerative Disease, Motor Neuron Disease
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2016
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ALS clinic patients at MDA/ALS Center of Hope.
Who may be able to join
- Medical Subjects:
- Be able to give consent themselves or via a legally authorized representative.
- Diagnosed with a neuromuscular disease and have limited ability to communicate.
- Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones.
- Be able to understand and remember instructions concerning participation.
- Healthy control subjects:
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- Be able to consent to give consent themselves or via a legally authorized representative.
- Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones.
- Be able to understand and remember instructions concerning participation.
Who cannot join
- Individuals with cognitive impairments that would impact their ability to follow the instructions
Trial locations and contacts
1 site in 1 country.
United States1 site
MDA/ALS Center of Hope
Philadelphia, Pennsylvania, 19107
About this study
Official title: EEG-Based Brain-Computer Interface Project for Individuals With ALS
Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular condition characterized by weakness, muscle wasting, fasciculations and increased reflexes. Depending on the site of onset, individuals with ALS progressively lose control of their skeletal muscles; bulbar or the extremities. As symptoms worsen and spread, muscle atrophy becomes apparent and upper motor neuron symptoms such as spasticity complicate gait (in lower limb involvement) and manual dexterity (in upper limb involvement). The patients progress to a state of profound disability and have great difficulty in communicating; some may even be entirely "locked in" to their bodies. The capacity for simple communication could greatly improve their quality of life.
New technologies are giving people with disabilities alternate communication and control options. One such instrument is the EEG-based Brain-Computer Interface (BCI) which can provide both communication and control functions to those who have lost muscle control. By recording electroencephalographic (EEG) signals or brain waves from the scalp and then decoding them, the Wadsworth BCI allows people to make selections on a computer screen [i] In this study we will be investigating the feasibility of using EEG-based Brain-Computer Interface technology as a communication solution for individuals with ALS. The specific question addressed will be: Can individuals with ALS use the BCI for communication when they present with extreme loss of neuromuscular control and severe communication impairments? The goal of the project is to determine whether this device is a practical and realistic means for individuals with ALS to communicate. The study is intended to evaluate both the complexity of the system and the degree to which each participant will be able to communicate. Trials will consist of asking the subject to follow a series of simple instructions and complete certain tasks while using the BCI.
This study design requires that the individual live in the Philadelphia region. Please contact the Wadsworth Center of the New York State Department of Health and State University of New York at Albany directly if you reside outside of this area.
Read the detailed description
This study design requires that the individual live in the Philadelphia region. Please contact the Wadsworth Center of the New York State Department of Health and State University of New York at Albany directly if you reside outside of this area.
- Keywords
- Amyotrophic Lateral Sclerosis, Cerebrospinal Fluid, Neurodegenerative Disease, Motor Neuron Disease, Autonomic Nervous System, Neurodegenerative Diseases, Movement Disorders
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Neurodegenerative Diseases, Motor Neuron Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALS | Subjects having either definite or probable ALS by El Escorial Criteria. | |
| Non-ALS | Subjects not having either definite or probable ALS by El Escorial Criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCI Accuracy
Measurement of percent spelling accuracy of the BCI system will be a main factor in determining usability of the system.
Measured: 1 session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2016
- Study completionDec 2016
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- MDA/ALS Center of Hope
- Responsible party
- Sponsor
- Investigators
- Terry Heiman-Patterson, MD, Principal investigator, MDA/ALS Center of Hope
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718458
- Sponsor's protocol ID
- Internal-17016
- Acronym
- BCI
- Status last verified
- Mar 2017
- First submitted
- 14 Jul 2008
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG-Based Brain-Computer Interface Project for Individuals With ALS
- ClinicalTrials.gov ID
- NCT00718458
- Acronym / sponsor ID
- BCI / Internal-17016
- Keywords
- Amyotrophic Lateral Sclerosis, Cerebrospinal Fluid, Neurodegenerative Disease, Motor Neuron Disease, Autonomic Nervous System, Neurodegenerative Diseases, Movement Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Collaborators
- MDA/ALS Center of Hope
- Study start
- Aug 2007
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jul 2008 (estimated)
- 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.
Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular condition characterized by weakness, muscle wasting, fasciculations and increased reflexes. Depending on the site of onset, individuals with ALS progressively lose control of their skeletal muscles; bulbar or the extremities. As symptoms worsen and spread, muscle atrophy becomes apparent and upper motor neuron symptoms such as spasticity complicate gait (in lower limb involvement) and manual dexterity (in upper limb involvement). The patients progress to a state of profound disability and have great difficulty in communicating; some may even be entirely "locked in" to their bodies. The capacity for simple communication could greatly improve their quality of life.
New technologies are giving people with disabilities alternate communication and control options. One such instrument is the EEG-based Brain-Computer Interface (BCI) which can provide both communication and control functions to those who have lost muscle control. By recording electroencephalographic (EEG) signals or brain waves from the scalp and then decoding them, the Wadsworth BCI allows people to make selections on a computer screen [i] In this study we will be investigating the feasibility of using EEG-based Brain-Computer Interface technology as a communication solution for individuals with ALS. The specific question addressed will be: Can individuals with ALS use the BCI for communication when they present with extreme loss of neuromuscular control and severe communication impairments? The goal of the project is to determine whether this device is a practical and realistic means for individuals with ALS to communicate. The study is intended to evaluate both the complexity of the system and the degree to which each participant will be able to communicate. Trials will consist of asking the subject to follow a series of simple instructions and complete certain tasks while using the BCI.
This study design requires that the individual live in the Philadelphia region. Please contact the Wadsworth Center of the New York State Department of Health and State University of New York at Albany directly if you reside outside of this area.
Detailed description
This study design requires that the individual live in the Philadelphia region. Please contact the Wadsworth Center of the New York State Department of Health and State University of New York at Albany directly if you reside outside of this area.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS | – | –Subjects having either definite or probable ALS by El Escorial Criteria. |
| Non-ALS | – | –Subjects not having either definite or probable ALS by El Escorial Criteria. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ALS clinic patients at MDA/ALS Center of Hope.
Key inclusion criteria (9 listed)
- Be able to give consent themselves or via a legally authorized representative.
- Diagnosed with a neuromuscular disease and have limited ability to communicate.
- Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones.
- Be able to understand and remember instructions concerning participation.
- Be able to consent to give consent themselves or via a legally authorized representative.
Key exclusion criteria (1 listed)
- Individuals with cognitive impairments that would impact their ability to follow the instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BCI Accuracy
Time frame: 1 session
Measurement of percent spelling accuracy of the BCI system will be a main factor in determining usability of the system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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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.
Terry Heiman-Patterson, MD principal investigator
MDA/ALS Center of Hope
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Neurodegenerative Disease, run by Drexel University College of Medicine 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 9 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: finished, as of the sponsor's last update on 30 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BCI Accuracy (time frame: 1 session). 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 30 Mar 2017.