Non-invasive BCI-controlled Assistive Devices

Официальное название

Non-invasive Brain-computer Interfaces for Control of Assistive Devices

Обзор

Injuries affecting the central nervous system may disrupt the cortical pathways to muscles causing loss of motor control. Nevertheless, the brain still exhibits sensorimotor rhythms (SMRs) during movement intents or motor imagery (MI), which is the mental rehearsal of the kinesthetics of a movement without actually performing it. Brain-computer interfaces (BCIs) can decode SMRs to control assistive devices and promote functional recovery. Despite rapid advancements in non-invasive BCI systems based on EEG, two persistent challenges remain: First, the instability of SMR patterns due to the non-stationarity of neural signals, which may significantly degrade BCI performance over days and hamper the effectiveness of BCI-based rehabilitation. Second, differentiating MI patterns corresponding to fine hand movements of the same limb is still difficult due to the low spatial resolution of EEG. To address the first challenge, subjects usually learn to elicit reliable SMR and improve BCI control through longitudinal training, so a fundamental question is how to accelerate subject training building upon the SMR neurophysiology. In this study, the investigators hypothesize that conditioning the brain with transcutaneous electrical spinal stimulation, which reportedly induces cortical inhibition, would constrain the neural dynamics and promote focal and strong SMR modulations in subsequent MI-based BCI training sessions - leading to accelerated BCI training. To address the second challenge, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to the voluntary activation of the primary motor cortex through MI can help differentiate patterns of activity associated with different hand movements of the same limb by consistently recruiting the separate neural pathways associated with each of the movements within a closed-loop BCI setup. The investigators study the neuroplastic changes associated with training with the two stimulation modalities.

Вмешательства

• Устройство NMES Feedback
  Electroencephalography (EEG) signals will be recorded from subjects as they perform cued tasks for flexing/extending their non-dominant hand. The signals will be processed and classified in real-time using machine learning algorithms to trigger electrical stimulation on the flexors/extensors of the targeted arm contingent to the detection of a subject-specific flexion/extension EEG patterns.
• Устройство Visual Feedback
  Electroencephalography (EEG) - recorded from subjects as they perform cued motor imagery (MI) tasks - are classified in real-time using a subject-specific BCI decoder,. The output classification probability of the decoder is accumulated using exponential smoothing and translated into continuous visual feedback by means of a bar - on a computer screen - that moves to the right or left in response to classification of one or the other MI task.
• Устройство TESS
  Transcutaneous Electrical Spinal Stimulation (TESS) is applied over the C5-C6 spinal segment for 20 minutes at 30Hz with 5kHz carrier frequency.

Первичные конечные точки

• Change in the BCI command delivery performance [Срок оценки: immediately after each intervention session and up to one week after all sessions]
• Change in the focality and Strength of SMR Modulation [Срок оценки: immediately after each intervention session and up to one week after all sessions]

Вторичные конечные точки (6)

• Stability of Motor Imagery features [Срок оценки: immediately after each intervention session and one-day after all sessions]
• Separability of Motor Imagery features [Срок оценки: immediately after each intervention session and one-day after all sessions]
• Changes in motor-evoked potential amplitude [Срок оценки: immediately after each intervention session and one-day after all sessions]
• Changes in electroencephalography functional connectivity [Срок оценки: immediately after each intervention session and one-day after all sessions]
• Change in focality of fMRI activation for different imagined movements [Срок оценки: immediately after each intervention session and one-day after all sessions]
• More discriminable fMRI activations for different imagined movements [Срок оценки: immediately after each intervention session and one-day after all sessions]

Критерии участия

Критерии включения

• Able-bodied participants:

• good general health
• normal or corrected vision
• no history of neurological/psychiatric disease
• ability to read and understand English (Research Personnel do not speak Spanish)
• Subjects with motor disabilities

• motor deficits due to: unilateral and bilateral stroke / spinal cord injury / motor neuron diseases (i.e. amyotrophic lateral sclerosis, spino-cerebellar ataxia, multiple sclerosis) / muscular diseases (i.e. myopathy) / traumatic or neurological pain / movement disorders (i.e. cerebral palsy) / orthopedic / traumatic brain injury / brain tumors
• normal or corrected vision
• ability to read and understand English
• ability to provide informed consent

Критерии исключения

• Subjects with motor disabilities

• short attentional spans or cognitive deficits that prevent the subject from concentrating during the whole experimental session
• heavy medication affecting the central nervous system (including vigilance)
• concomitant serious illness (e.g., metabolic disorders)
• All participants

• factors hindering EEG/EMG acquisition and the delivery of non-invasive electrical stimulation (e.g., skin infection, wounds, dermatitis, metal implants under electrodes)
• criteria identified in safety guidelines for MRI and TMS, in particular metallic implants

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• The University of Texas at Austin — Austin

Идентификаторы

NCT: NCT05183152 · 2020030073

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗