Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03787420
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
ALS (Amyotrophic Lateral Sclerosis) Other: communication system Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019


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.




Primary Outcome Measures :
  1. Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs [ Time Frame: 30mins ]
    To comprehensively assess the perceived supportive care needs of patients with ALS.

  2. Part 2 - Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revisedclinical study [ Time Frame: one week ]
    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 :
  1. Part 2 - Beck Depression Inventoryc [ Time Frame: one week ]
    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.

  2. Caregiver Burden Scale [ Time Frame: one week ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787420


Contacts
Layout table for location contacts
Contact: Cheng Liang Chou +8862-28757296 cl_chou@vghtpe.gov.tw
Contact: SI-HUEI LEE +886938591985 leesihuei@gmail.com

Locations
Layout table for location information
Taiwan
Cancer Center, Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Cheng Liang Chou    +8862-28757296    cl_chou@vghtpe.gov.tw   
Contact: SI-HUEI LEE    +886938591985    leesihuei@gmail.com   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

Layout table for additonal information
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03787420     History of Changes
Other Study ID Numbers: 107-3011-F-027-002-
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases