Amyotrophic Lateral SclerosisNCT00718497
Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population
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
New technologies are giving people with motor disabilities alternative communication and control channels. The investigators are interested in using the Cyberlink Control System as a hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Neurodegenerative Disease, Motor Neuron Disease
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2012
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ALS clinic patients at MDA/ALS Center of Hope.
Who may be able to join
- Diagnosis of definite or possible ALS by the El Escorial Criteria
- Between ages of 18 to 89 years.
- Scored two or less in the ALS FRS category 1 (Speech)
- Scored two or less in the ALS FRS category 4 (Handwriting)
- Cognitively intact with no other neurological diseases
- No unstable medical problems
Who cannot join
- Any subject not meeting the inclusion criteria
- Patients unable to give informed consent either themselves or via a legally authorized personnel.
- Patients diagnosed with neurological problems other than ALS (upon examination by the principal investigator)
Trial locations and contacts
1 site in 1 country.
United States1 site
MDA/ALS Center of Hope
Philadelphia, Pennsylvania, 19107
About this study
New technologies are giving people with motor disabilities alternative communication and control channels. The investigators are interested in using the Cyberlink Control System as a hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS). The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye movements.
The benefit of this study may be of substantial value to many people with severe motor impairment. Additionally, it is hoped that some of the study subjects may benefit by incorporating hands-free computer use into their daily lives.
This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily communication compared to the standard manual letter board.
- 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Taken to Complete a Sentence
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 completionMay 2012
- Study completionMay 2012
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 25 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
- NCT00718497
- Sponsor's protocol ID
- Internal-17018
- Status last verified
- Mar 2013
- First submitted
- 14 Jul 2008
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population
- ClinicalTrials.gov ID
- NCT00718497
- Acronym / sponsor ID
- Internal-17018
- 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
- 25 participants (actual)
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Collaborators
- MDA/ALS Center of Hope
- Study start
- Aug 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (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.
New technologies are giving people with motor disabilities alternative communication and control channels. The investigators are interested in using the Cyberlink Control System as a hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS). The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye movements.
The benefit of this study may be of substantial value to many people with severe motor impairment. Additionally, it is hoped that some of the study subjects may benefit by incorporating hands-free computer use into their daily lives.
This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily communication compared to the standard manual letter board.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALS | – | –Subjects having either definite or probable ALS by El Escorial Criteria. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALS clinic patients at MDA/ALS Center of Hope.
Key inclusion criteria (6 listed)
- Diagnosis of definite or possible ALS by the El Escorial Criteria
- Between ages of 18 to 89 years.
- Scored two or less in the ALS FRS category 1 (Speech)
- Scored two or less in the ALS FRS category 4 (Handwriting)
- Cognitively intact with no other neurological diseases
Key exclusion criteria (3 listed)
- Any subject not meeting the inclusion criteria
- Patients unable to give informed consent either themselves or via a legally authorized personnel.
- Patients diagnosed with neurological problems other than ALS (upon examination by the principal investigator)
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
Time Taken to Complete a Sentence
Time frame: 1 session
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 5 Mar 2013.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 1
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
ALS (Amyotrophic Lateral Sclerosis)
Active, not recruiting
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Neurological Disorder, ALS (Amyotrophic Lateral Sclerosis)
RecruitingObservational study
ASSESS ALL ALS Study
Amyotrophic Lateral Sclerosis
Not yet recruitingPhase 1
Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS
Amyotrophic Lateral Sclerosis ALS
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 6 inclusion and 3 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 5 Mar 2013. 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?
Time Taken to Complete a Sentence (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 5 Mar 2013.