An interventional study of NMES Feedback and Visual Feedback in Motor Disorders, Healthy and Spinal Cord Injuries, sponsored by University of Texas at Austin. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Basic science
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.
73 studies on the registry are indexed under Motor Disorders; 24 are open to participants now.
This study's planned enrollment of 100 is above the median of 41 across 52 interventional studies indexed under Motor Disorders.
Browse Motor Disorders studies →University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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Able-bodied participants:
Subjects with motor disabilities
Exclusion Criteria:
Subjects with motor disabilities
All participants
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transcutaneous Electrical Spinal Stimulation (TESS) is applied for 20 minutes prior to BCI training sessions. Following TESS, BCI training is performed with visual feedback contingent to motor imagery as detected by a closed-loop BCI.
Device: Visual Feedback · Device: TESS
Conventional BCI training is performed with visual feedback contingent to the imagination of right versus left hand movements as detected by a closed-loop BCI.
Device: Visual Feedback
BCI training is performed with NMES instead of Visual feedback. NMES is delivered over the flexors/extensors of the forearm contingent to the imagination of same-hand wrist and fingers flexion versus extension as detected by a closed-loop BCI.
Device: NMES Feedback
Conventional BCI training is performed with visual feedback contingent to the imagination of same-hand wrist and fingers flexion versus extension as detected by a closed-loop BCI.
Device: Visual 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.
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.
Transcutaneous Electrical Spinal Stimulation (TESS) is applied over the C5-C6 spinal segment for 20 minutes at 30Hz with 5kHz carrier frequency.
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
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
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
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
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
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
Change in focality of fMRI activation for different imagined movements
The clusters of significant activation during MI of different movements would be more focal in the associated region of the motor area Continuous measure, the more the better.
Time frame: immediately after each intervention session and one-day after all sessions
More discriminable fMRI activations for different imagined movements
The activation associated with different MI tasks would be more discriminable from BOLD signals. Continuous measure, the more the better.
Time frame: immediately after each intervention session and one-day after all sessions
Plan to share: Yes
Supporting information: Study protocol
Time frame: All data will be made available by the online publication date
Access criteria: Data will be placed in public servers for any interested researcher to access it
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