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

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.

Study Overview

• Status: Unknown
• Conditions: ALS (Amyotrophic Lateral Sclerosis)
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Cancer Center, Taipei Veterans General Hospital
    • Contact: Cheng Liang Chou; Phone Number: +8862-28757296; Email: cl_chou@vghtpe.gov.tw
    • Contact: SI-HUEI LEE; Phone Number: +886938591985; Email: leesihuei@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: traditional communication system	Other: communication 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.
Experimental: intelligent communication system	Other: communication 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs	To comprehensively assess the perceived supportive care needs of patients with ALS.	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.	one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: December 24, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 107-3011-F-027-002-

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No