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

NCT ID: NCT03787420

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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ALS (Amyotrophic Lateral Sclerosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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traditional communication system

Group Type ACTIVE_COMPARATOR

communication system

Intervention Type OTHER

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.

intelligent communication system

Group Type EXPERIMENTAL

communication system

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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


* 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.
* The questionnaire cannot be completed without the assistance of others.

Part two:


* 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Center, Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Cheng Liang Chou

Role: CONTACT

Phone: +8862-28757296

Email: [email protected]

SI-HUEI LEE

Role: CONTACT

Phone: +886938591985

Email: [email protected]

Facility Contacts

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Cheng Liang Chou

Role: primary

SI-HUEI LEE

Role: backup

Other Identifiers

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107-3011-F-027-002-

Identifier Type: -

Identifier Source: org_study_id