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

NCT03787420 | Unknown

• 1 other identifier: 107-3011-F-027-002-
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Part 2 - Beck Depression Inventoryc

  one week

• Caregiver Burden Scale

  one week

Study Arms (2)

traditional communication system

ACTIVE COMPARATOR

Other: communication system

intelligent communication system

EXPERIMENTAL

Other: communication system

Interventions

communication system 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; traditional communication system

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Cancer Center, Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Cheng Liang Chou

CONTACT

+8862-28757296; cl_chou@vghtpe.gov.tw

SI-HUEI LEE

CONTACT

+886938591985; leesihuei@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: December 26, 2018
• Study Start: September 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 26, 2018

Record last verified: 2018-10

Locations

TW (1)