Evaluation of Non-invasive Control Interfaces for Operating Assistive Devices for Tetraplegic Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy indicators
研究概览
简要总结
Neurinnov, in collaboration with the CBV USSAP center and the CAMIN INRIA team, has conducted clinical investigations using various control interfaces, including EMG, IMU, contact sensors, and voice commands, to operate a motor neuroprosthesis. This neuroprosthesis is based on neural electrical stimulation, enabling the activation of multiples muscles via a single electrode. The clinical investigations have successfully demonstrated the feasibility of achieving grasping movements induced by neural electrical stimulation, which are controlled by the participant through external interfaces.
These external interfaces were based on existing technologies but were only suitable for research purposes due to their lack of portability. The current investigation aims to validate fully portable interfaces designed by Neurinnov, which are intended to be integral components of a future medical device that includes an implanted stimulator and its neural electrodes. The study's goal is to demonstrate that these interfaces can be used by participants with sufficient success rate (clinical performance) to support daily use.
Our main hypothesis is that the participants can effectively use at least two of the six control interfaces presented to them to detect their intention to perform a motor action within a software environment under constant conditions. These interfaces include voice commands, inertial measurement unit (IMU) sensors, surface electromyography (EMG) sensors, switch, joystick, and earswitch.
详细描述
Various control interfaces (CIs) are used to capture user intent for operating assistive devices. In recent years, several methods have been developed to detect user intent for controlling invasive motor neuroprostheses for upper limbs. The Freehand System® utilized an external shoulder position sensor on the contralateral side to detect user intent and control hand grasp stimulation. In some studies, a switch was integrated with the sensor to turn the system on and off and to select the type of grasp (palmar or lateral). Brain-computer interface (BCI) systems based on electroencephalography (EEG) have also been employed. The Implantable Stimulator-Telemeter ('IST-10'), the second generation of the Freehand, had ten stimulation channels and was used with an implantable joint angle sensor. The third generation, the Implanted Stimulator Telemeter (IST-12), used myoelectric signals. However, no direct comparison has been made between these different modalities, nor has their relevance been determined.
Therefore, this study aims to evaluate the performance (efficacy: reliability and precision) of six non-invasive control interfaces. The efficacy criterion is defined by the ability to reliably and accurately control a motor action as illustrated by software on a screen. The six control interfaces are: (1) inertial measurement unit (IMU) sensors that record movements of the contralateral shoulder; (2) surface electromyography (EMG) sensors that capture voluntary muscle contractions of the contralateral limb; (3) a pressure sensor button (switch sensor); (4) a pressure sensor joystick (joystick sensor); (5) a voice recognition sensor (voice sensor) that incorporates a machine learning model capable of recognizing specific words spoken by the participant; and (6) an Ear-Switch® sensor that detects movements of a muscle inside the ear, the tensor tympani.
The study will be conducted over six sessions:
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(V1) Selection Visit: The selection visit will be conducted by the coordinating investigator, who will monitor the participant throughout the trial.
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(V2) Inclusion Visit: This visit will include:
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Clinical examination
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Collection of the signed consent form
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Audio recordings of key words to personalize the speech recognition algorithms
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(V3 to V5) Experimental Visits:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury defined by an AIS A, B or C score (AIS A, B or C): complete or incomplete motor deficit below the lesion. This is a standard for describing spinal cord injuries that has been internationally agreed upon.
- •Spinal cord injury at the neurological level > C7
- •Age greater than or equal to 18 and less than or equal to 80 years
- •A history of more than 3 months of neurological stability, with no changes in muscle testing.
- •Participants capable of following instructions for testing and providing feedback on the use of the device.
- •Participants who have signed the informed consent form to participate in the study after being fully informed.
- •Participants affiliated with a social security system (either as a beneficiary or a dependent), excluding those covered by State Medical Aid (AME).
排除标准
- •Participant deprived of liberty (by judicial or administrative decision).
- •Adult participants are under legal protection or unable to provide informed consent.
- •Participation in another ongoing clinical trial.
- •Unstable psychiatric condition.
- •Severe cognitive impairment.
- •Unstable acute medical condition
- •Insufficient proficiency in spoken and written French.
结局指标
主要结局
Efficacy indicators
时间窗: At Day 1
Success rate: describes the ability of a control interface to execute requested functions under specified conditions Evaluation criterion: (Number of correctly recognized commands) / (Number of correctly recognized commands + Number of incorrectly recognized commands). Rate in percentage %
次要结局
- Time workload indicators(At Day 1)
- Indicator of feasibility: Ease of installation, calibration, and learning of each control interface (CI)(At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4)
- Indicator of feasibility: Ease of placing the control interface(At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4)
- Indicator of feasibility: Ease of learning to use the control interface(At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4)
- Indicator of feasibility: User feedback concerning usability of the control interface(At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4)
- Indicator of tolerance : Pain experienced during and after using the interface(During the experimentation at Day 2 and 3)
- Indicator of tolerance : Adverse effects(During the experimentation at Day 2 and 3)
- Indicators of satisfaction, comfort, pleasure of use and subjective workload(At Day 3)
- Indicators that a static and dynamic intensity value has been reached in a predetermined time (difference between target and initial value)(At Day 7)