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Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS.

Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03787420
Enrollment
60
Registered
2018-12-26
Start date
2018-09-01
Completion date
2019-12-31
Last updated
2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Brief 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 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.

Interventions

OTHERcommunication system

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.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs30minsTo comprehensively assess the perceived supportive care needs of patients with ALS.
Part 2 - Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revisedclinical studyone weekWe 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.

Secondary

MeasureTime frameDescription
Part 2 - Beck Depression Inventorycone weekWe 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.
Caregiver Burden Scaleone weekWe 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.

Countries

Taiwan

Contacts

Primary ContactCheng Liang Chou
cl_chou@vghtpe.gov.tw+8862-28757296
Backup ContactSI-HUEI LEE
leesihuei@gmail.com+886938591985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026