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

Not Applicable

• Conditions: ALS (Amyotrophic Lateral Sclerosis)
• Interventions: Other: communication system

• Registration Number: NCT03787420
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2018-10
• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-12-24
• Last Update Submitted: 2018-12-24
• Study First Posted: 2018-12-26
• Last Update Posted: 2018-12-26
• Primary Completion: 2019-08-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intelligent communication system	communication system	-
traditional communication system	communication system	-

Primary Outcome Measures

Name	Time	Method
Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs	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	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.

Secondary Outcome Measures

Name	Time	Method
Part 2 - Beck Depression Inventoryc	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 degree of depression of life in patient with ALS.
Caregiver Burden Scale	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 burden in patient's caregiver.

Trial Locations

Locations (1)

Cancer Center, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan