ALS (Amyotrophic Lateral Sclerosis)NCT03787420
Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS.
A study testing communication system in people with ALS (Amyotrophic Lateral Sclerosis), run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This project aims to develop a smart communication system for patients with amyotrophic lateral sclerosis (ALS), especially for stage 3 and stage 4 (late stage). Patients with ALS will be able to communicate with outer environment by means of mental control or eye tracking control, which would increase their life… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- What is being tested?
- communication system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2018to 31 Dec 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ALS diagnostic criteria (Brooks et al., 2000).Must have the following characteristics:
- Degeneration of motor neurons (LMN) by clinical, electrophysiological or neuropathological evidence.
- Degeneration of upper motor neurons (UMN) is demonstrated by clinical examination.
- According to the medical history or examination, the symptoms or signs gradually disappear in a certain part.
- Also, there are no features:
- Electrophysiological or pathological evidence of other diseases that may explain signs of LMN and/or UMN degradation
Show all 14Show fewer
- Neuroimaging evidence of other diseases that may explain the observed clinical electrophysiological signs.
- Use Mandarin as the main language.
- Age limits minimum is 20
- ALS diagnostic criteria (Brooks et al., 2000).
- Use Mandarin as the main language.
- Age limits minimum is 20
- In everyday oral communication, people who are consciously difficult.
- Ability to perform equipment wear and system operators.
Who cannot join
- Concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis.
- The questionnaire cannot be completed without the assistance of others.
- Part two:
- Concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis.
- After correction, the visual acuity cannot see the communication board.
- The scalp is sensitive or there is deep brain stimulation, etc. It is not applicable to brain wave measurement.
- -The questionnaire cannot be completed without the assistance of others.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cancer Center, Taipei Veterans General Hospital
Taipei, 11217
Cheng Liang Chou, +8862-28757296, cl_chou@vghtpe.gov.tw
SI-HUEI LEE, +886938591985, leesihuei@gmail.com
About this study
Official title: Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS
This project aims to develop a smart communication system for patients with amyotrophic lateral sclerosis (ALS), especially for stage 3 and stage 4 (late stage). Patients with ALS will be able to communicate with outer environment by means of mental control or eye tracking control, which would increase their life quality. This integrated research project includes experts from different domains and proposes a solution for smart communication system.
Read the detailed description
A multi-function brain- computer interface (BCI) communication system will be developed by combining a BCI system (subproject 1) and a 3D electro-cap (subproject 3). Then, this system and an eye-controlled device (subject 2) are further integrated to a smart communication system. The outputs of the system are presented with the original voice the ALS patients, which will be achieved by using the voice reconstruction technology (subproject 4) in this project. All the user-interfaces of the BCI and eye tracking systems will be re-deigned by employing human factors engineering to increase the usability of the proposed smart communication system for ALS. Finally, the validity of the system in improving the life quality of ALS will be assessed through clinical study.
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Being tested
- communication system
- 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.
communication systemOther
We will use the questionnaire "Amyotrophic Lateral Sclerosis Supportive Care Needs ,Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, Beck Depression Inventory and Caregiver Burden Scale.
| Study group | Role | What they receive |
|---|---|---|
| traditional communication system | Active comparator | Not described Receives: Other: communication system |
| intelligent communication system | Experimental | Not described Receives: Other: communication system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs
To comprehensively assess the perceived supportive care needs of patients with ALS.
Measured: 30mins
Part 2 - Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revisedclinical study
We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the quality of life in patient with ALS.
Measured: one week
Secondary outcomes (2)
Part 2 - Beck Depression Inventoryc
We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the degree of depression of life in patient with ALS.
Measured: one week
Caregiver Burden Scale
We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the burden in patient's caregiver.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Sep 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787420
- Sponsor's protocol ID
- 107-3011-F-027-002-
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS
- ClinicalTrials.gov ID
- NCT03787420
- Acronym / sponsor ID
- 107-3011-F-027-002-
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Dec 2018 (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.
This project aims to develop a smart communication system for patients with amyotrophic lateral sclerosis (ALS), especially for stage 3 and stage 4 (late stage). Patients with ALS will be able to communicate with outer environment by means of mental control or eye tracking control, which would increase their life quality. This integrated research project includes experts from different domains and proposes a solution for smart communication system.
Detailed description
A multi-function brain- computer interface (BCI) communication system will be developed by combining a BCI system (subproject 1) and a 3D electro-cap (subproject 3). Then, this system and an eye-controlled device (subject 2) are further integrated to a smart communication system. The outputs of the system are presented with the original voice the ALS patients, which will be achieved by using the voice reconstruction technology (subproject 4) in this project. All the user-interfaces of the BCI and eye tracking systems will be re-deigned by employing human factors engineering to increase the usability of the proposed smart communication system for ALS. Finally, the validity of the system in improving the life quality of ALS will be assessed through clinical study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional communication system | Active comparator | Other: communication system |
| intelligent communication system | Experimental | Other: communication system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ALS diagnostic criteria (Brooks et al., 2000).Must have the following characteristics:
- Electrophysiological or pathological evidence of other diseases that may explain signs of LMN and/or UMN degradation
- Neuroimaging evidence of other diseases that may explain the observed clinical electrophysiological signs.
- ALS diagnostic criteria (Brooks et al., 2000).
- Use Mandarin as the main language.
Key exclusion criteria (7 listed)
- Concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis.
- The questionnaire cannot be completed without the assistance of others.
- Concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis.
- After correction, the visual acuity cannot see the communication board.
- The scalp is sensitive or there is deep brain stimulation, etc. It is not applicable to brain wave measurement.
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 |
|---|---|---|
| communication systemWe will use the questionnaire "Amyotrophic Lateral Sclerosis Supportive Care Needs ,Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, Beck Depression Inventory and Caregiver Burden Scale. | Other | intelligent communication system, traditional communication system |
Primary outcome
Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs
Time frame: 30mins
To comprehensively assess the perceived supportive care needs of patients with ALS.
Part 2 - Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revisedclinical study
Time frame: one week
We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the quality of life in patient with ALS.
2 secondary outcomes
Part 2 - Beck Depression Inventoryc
Time frame: one week
Caregiver Burden Scale
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication system in people with ALS (Amyotrophic Lateral Sclerosis), run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 14 inclusion and 7 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 26 Dec 2018. 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 Taiwan. 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 Cheng Liang Chou (+8862-28757296, cl_chou@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs (time frame: 30mins). The study lists 2 primary outcomes in all. 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 26 Dec 2018.