Development and Test of a Headset for BCI Until Obtaining an Efficient and Comfortable System That Can be Used in Daily Practice by ALS People (TECH-ICOPA)
Primary Purpose
Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Spinal Cord Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
New headset prototype
Sponsored by
About this trial
This is an interventional other trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion criteria
- Age ≥ 18 years old
- For women of childbearing potential, use of contraception for the duration of the study
- Diagnosis of suspected ALS, possible, probable with ENMG, probable, defined according to the criteria of the World Federation of Neurology (revised El Escorial criteria, Airlie House Conference 1998)
- Understanding of the objective of the study after describing the principle of the P300 Speller and the course of the study
- Ability to follow the study procedure and to comply with the schedule of visits when entering the study
- Expression of a P300 wave under the conditions of the study
Exclusion criteria
- Psychiatric illness or dementia that may interfere with the patient's ability to follow study procedures
- History of photosensitive epilepsy
- Patient subject to protective measures
- Non-correctable visual disturbances
- Limited ability to concentrate.
- Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
- Persons deprived of their liberty by a judicial or administrative decision
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALS people with severe disability
Arm Description
Outcomes
Primary Outcome Measures
prototype set-up time
The time for setting up the prototype will be defined in seconds by the time elapsed between the start and stop of the stopwatch, the installation sequence being defined as follows:
start of the stopwatch: patient seated, equipment positioned on the table
patient or caregiver (depending on the patient's motor skills; 1 person): takes the prototype and positions it on the (patient's) skull
stopwatch stop: when the prototype is set up ready to operate
Quality of the impedance of each electrode
The quality will be considered satisfactory if the impedance value of each of the electrodes is ≤ 1 000 kOhm, according to literature data.
Number of errors during calibration
The number of errors in copying the 10 letters during the calibration phase will be counted.
Patient/caregiver satisfaction
The evaluation of patient and caregiver satisfaction will be carried out using visual analogue scales (VAS rated from 0 to 10) on their feelings (patient/caregiver) of use.
Secondary Outcome Measures
Full Information
NCT ID
NCT04380649
First Posted
April 22, 2020
Last Updated
July 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04380649
Brief Title
Development and Test of a Headset for BCI Until Obtaining an Efficient and Comfortable System That Can be Used in Daily Practice by ALS People
Acronym
TECH-ICOPA
Official Title
Brain Computer Interface Prototype Development for Assisted Alternative Communication in ALS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
August 13, 2024 (Anticipated)
Study Completion Date
August 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
"Brain-computer interfaces (BCIs) are computer-based systems that acquire brain signals, analyze them, and translate them into commands that are relayed to an output device to carry out a desired action. BCIs represent a very active and promising field of research among devices for people with severe motor disabilities. As the currently available systems correspond to research prototypes, they are not adapted to daily live situations. On the other hand, some systems have recently been commercialized, principally for video games but they are not satisfactory for use as a substitute technology in disability.
A BCI's prototype for alternative communication using a virtual keyboard, the P300 Speller, has been developed by the National Institute for Research in Digital Science and Technology (Athena team - Nice University). This prototype includes an EEG-cap with gel based active electrodes. A recent study conducted on 20 patients with ALS (University Hospital, Nice) demonstrated the usability of the system and the patient satisfaction concerning the ease of use and utility. To achieve a system that can be used in daily live in severely disabled patients, technical developments are necessary.
The investigators have conceptualized and developed an ergonomic, comfortable, headset, including dry electrodes to allow a prolonged use of the system.
The purpose of the study conducted all along the development of the headset is to improve the developed system until a successful system is achieved. This study is a monocentric usability study conducted on ALS people.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Spinal Cord Diseases, Alternative Communication Devices, Neurodegenerative Diseases, Nervous System Diseases, Neuromuscular Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALS people with severe disability
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
New headset prototype
Intervention Description
creation of a new headset prototype for using the P300 Speller, comfortable to use in everyday life by people with disabilities.
Primary Outcome Measure Information:
Title
prototype set-up time
Description
The time for setting up the prototype will be defined in seconds by the time elapsed between the start and stop of the stopwatch, the installation sequence being defined as follows:
start of the stopwatch: patient seated, equipment positioned on the table
patient or caregiver (depending on the patient's motor skills; 1 person): takes the prototype and positions it on the (patient's) skull
stopwatch stop: when the prototype is set up ready to operate
Time Frame
at 6 months
Title
Quality of the impedance of each electrode
Description
The quality will be considered satisfactory if the impedance value of each of the electrodes is ≤ 1 000 kOhm, according to literature data.
Time Frame
at 6 months
Title
Number of errors during calibration
Description
The number of errors in copying the 10 letters during the calibration phase will be counted.
Time Frame
at 6 months
Title
Patient/caregiver satisfaction
Description
The evaluation of patient and caregiver satisfaction will be carried out using visual analogue scales (VAS rated from 0 to 10) on their feelings (patient/caregiver) of use.
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Age ≥ 18 years old
For women of childbearing potential, use of contraception for the duration of the study
Diagnosis of suspected ALS, possible, probable with ENMG, probable, defined according to the criteria of the World Federation of Neurology (revised El Escorial criteria, Airlie House Conference 1998)
Understanding of the objective of the study after describing the principle of the P300 Speller and the course of the study
Ability to follow the study procedure and to comply with the schedule of visits when entering the study
Expression of a P300 wave under the conditions of the study
Exclusion criteria
Psychiatric illness or dementia that may interfere with the patient's ability to follow study procedures
History of photosensitive epilepsy
Patient subject to protective measures
Non-correctable visual disturbances
Limited ability to concentrate.
Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
Persons deprived of their liberty by a judicial or administrative decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène SORIANI
Phone
0492035504
Ext
+33
Email
soriani.mh@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Provence Alpes Cote d'Azur
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Helene SORIANI
Phone
0492035504
Ext
+33
Email
soriani.mh@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Marie-Helene SORIANI
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development and Test of a Headset for BCI Until Obtaining an Efficient and Comfortable System That Can be Used in Daily Practice by ALS People
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