ALS (Amyotrophic Lateral Sclerosis) Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Part one: Inclusion Criteria: - ALS diagnostic criteria (Brooks et al., 2000).Must have the following characteristics: 1. Degeneration of motor neurons (LMN) by clinical, electrophysiological or neuropathological evidence. 2. Degeneration of upper motor neurons (UMN) is demonstrated by clinical examination. 3. According to the medical history or examination, the symptoms or signs gradually disappear in a certain part. Also, there are no features: 1. Electrophysiological or pathological evidence of other diseases that may explain signs of LMN and/or UMN degradation 2. Neuroimaging evidence of other diseases that may explain the observed clinical electrophysiological signs. - Use Mandarin as the main language. - Age limits minimum is 20 Exclusion Criteria: - 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: Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Cancer Center, Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs | To comprehensively assess the perceived supportive care needs of patients with ALS. | 30mins | |
Primary | 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. | one week | |
Secondary | 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. | one week | |
Secondary | 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. | one week |
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