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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)

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: NCT04380649
Recruitment Status : Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Motor Neuron Disease Spinal Cord Diseases Alternative Communication Devices Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Device: New headset prototype Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Brain Computer Interface Prototype Development for Assisted Alternative Communication in ALS
Estimated Study Start Date : February 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025


Arm Intervention/treatment
Experimental: ALS people with severe disability Device: New headset prototype
creation of a new headset prototype for using the P300 Speller, comfortable to use in everyday life by people with disabilities.




Primary Outcome Measures :
  1. prototype set-up time [ Time Frame: at 6 months ]

    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

  2. Quality of the impedance of each electrode [ Time Frame: at 6 months ]
    The quality will be considered satisfactory if the impedance value of each of the electrodes is ≤ 1 000 kOhm, according to literature data.

  3. Number of errors during calibration [ Time Frame: at 6 months ]
    The number of errors in copying the 10 letters during the calibration phase will be counted.

  4. Patient/caregiver satisfaction [ Time Frame: at 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Age ≥ 18 years old
  2. For women of childbearing potential, use of contraception for the duration of the study
  3. 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)
  4. Understanding of the objective of the study after describing the principle of the P300 Speller and the course of the study
  5. Ability to follow the study procedure and to comply with the schedule of visits when entering the study
  6. Expression of a P300 wave under the conditions of the study

Exclusion criteria

  1. Psychiatric illness or dementia that may interfere with the patient's ability to follow study procedures
  2. History of photosensitive epilepsy
  3. Patient subject to protective measures
  4. Non-correctable visual disturbances
  5. Limited ability to concentrate.
  6. Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
  7. Persons deprived of their liberty by a judicial or administrative decision

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): NCT04380649


Contacts
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Contact: Marie-Hélène SORIANI 0492035504 ext +33 soriani.mh@chu-nice.fr

Locations
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France
CHU de Nice
Nice, Provence Alpes Cote d'Azur, France, 06000
Contact: Marie-Helene SORIANI    0492035504 ext +33    soriani.mh@chu-nice.fr   
Principal Investigator: Marie-Helene SORIANI         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04380649    
Other Study ID Numbers: 19-PP-18
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases