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

Primary Purpose

ALS (Amyotrophic Lateral Sclerosis)

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

communication system

About this trial

This is an interventional other trial for ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Electrophysiological or pathological evidence of other diseases that may explain signs of LMN and/or UMN degradation
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.

Sites / Locations

Cancer Center, Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

traditional communication system

intelligent communication system

Arm Description

Outcomes

Primary Outcome Measures

Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs

To comprehensively assess the perceived supportive care needs of patients with ALS.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03787420

First Posted

October 25, 2018

Last Updated

December 24, 2018

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT03787420

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

August 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ALS (Amyotrophic Lateral Sclerosis)

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

traditional communication system

Arm Type

Active Comparator

Arm Title

intelligent communication system

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

communication system

Intervention Description

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.

Primary Outcome Measure Information:

Title

Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs

Description

To comprehensively assess the perceived supportive care needs of patients with ALS.

Time Frame

30mins

Title

Part 2 - Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revisedclinical study

Description

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.

Time Frame

one week

Secondary Outcome Measure Information:

Title

Part 2 - Beck Depression Inventoryc

Description

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.

Time Frame

one week

Title

Caregiver Burden Scale

Description

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.

Time Frame

one week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Part one: Inclusion Criteria: ALS diagnostic criteria (Brooks et al., 2000).Must have the following characteristics: Degeneration of motor neurons (LMN) by clinical, electrophysiological or neuropathological evidence. Degeneration of upper motor neurons (UMN) is demonstrated by clinical examination. According to the medical history or examination, the symptoms or signs gradually disappear in a certain part. Also, there are no features: Electrophysiological or pathological evidence of other diseases that may explain signs of LMN and/or UMN degradation 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cheng Liang Chou

Phone

+8862-28757296

cl_chou@vghtpe.gov.tw

First Name & Middle Initial & Last Name or Official Title & Degree

SI-HUEI LEE

Phone

+886938591985

leesihuei@gmail.com

Facility Information:

Facility Name

Cancer Center, Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cheng Liang Chou

Phone

+8862-28757296

cl_chou@vghtpe.gov.tw

First Name & Middle Initial & Last Name & Degree

SI-HUEI LEE

Phone

+886938591985

leesihuei@gmail.com

12. IPD Sharing Statement

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

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