Clinical trial NCT03787420: 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
Overall status: UNKNOWN
Phase: NA
Conditions: ALS (Amyotrophic Lateral Sclerosis)
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-12-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs
timeFrame: 30mins
measure: Part 2 - Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revisedclinical study
timeFrame: one week
Secondary outcomes:
measure: Part 2 - Beck Depression Inventoryc
timeFrame: one week
measure: Caregiver Burden Scale
timeFrame: one week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cancer Center, Taipei Veterans General Hospital
Study officials:
References: