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

ALS (Amyotrophic Lateral Sclerosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787420
• Other study ID #: 107-3011-F-027-002-
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2018
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Cheng Liang Chou
• Phone: +8862-28757296
• Email: cl_chou[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 quality. This integrated research project includes experts from different domains and proposes a solution for smart communication system.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• ALS (Amyotrophic Lateral Sclerosis)
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Cancer Center, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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