Non-invasive BCI-controlled Assistive Devices

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Texas at Austin

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Factorial

Treatments tested in this trial

  • NMES Feedback

    Device

    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.

  • Visual Feedback

    Device

    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.

  • TESS

    Device

    Transcutaneous Electrical Spinal Stimulation (TESS) is applied over the C5-C6 spinal segment for 20 minutes at 30Hz with 5kHz carrier frequency.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: TESS BCI - Standard MI TaskExperimental treatment 2 interventions
Group B: Visual BCI - Standard MI TaskActive comparator 1 intervention
Group C: NMES BCI - Difficult MI TaskExperimental treatment 1 intervention
Group D: Visual BCI - Difficult MI TaskActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the BCI command delivery performance

The command delivery accuracy reflects the level of control of the subject when using the BCI. It measures the percentage of trials in which the subject-specific classifier that is used to differentiate the different imagined movements could accumulate enough evidence to support the presence of EEG patterns specifically associated with the imagined movement in those trials. The score is 0-100, and the higher the value, the better the outcome.

Time frame
immediately after each intervention session and up to one week after all sessions
2

Change in the focality and Strength of SMR Modulation

The focality of sensorimotor rhythm modulation is assessed from EEG using event-related desynchorinzation (ERD) and synchronization (ERS) over the motor area. Continuous measure, the higher the better

Time frame
immediately after each intervention session and up to one week after all sessions

Secondary outcomes

1

Stability of Motor Imagery features

The features corresponding to different motor imagery tasks become more stable at the end of the intervention.

Time frame
immediately after each intervention session and one-day after all sessions
2

Separability of Motor Imagery features

The features corresponding to different motor imagery tasks become more separable after the intervention.

Time frame
immediately after each intervention session and one-day after all sessions
3

Changes in motor-evoked potential amplitude

Continuous measure, the higher the better

Time frame
immediately after each intervention session and one-day after all sessions
4

Changes in electroencephalography functional connectivity

Continuous measure, the more significant changes the better

Time frame
immediately after each intervention session and one-day after all sessions

Other outcomes

Sponsors and contacts

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