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Non-invasive BCI-controlled Assistive Devices

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05183152
Enrollment
100
Registered
2022-01-10
Start date
2021-06-16
Completion date
2025-12-30
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Disorders, Healthy, Spinal Cord Injuries, Muscular Diseases, Motor Neuron Disease, Stroke, Traumatic Brain Injury, Movement Disorders, Multiple Sclerosis

Keywords

motor deficits, able-bodied, healthy, unilateral and bilateral stroke, spinal cord injury, motor neuron diseases, muscular diseases (i.e. myopathy), traumatic or neurological pain, movement disorders

Brief summary

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.

Interventions

DEVICENMES 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.

DEVICETESS

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

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

BCI Task x Stimulation Modality

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. 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) 2. 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

Exclusion criteria

1. 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) 2. 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

Design outcomes

Primary

MeasureTime frameDescription
Change in the BCI command delivery performanceimmediately after each intervention session and up to one week after all sessionsThe 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.
Change in the focality and Strength of SMR Modulationimmediately after each intervention session and up to one week after all sessionsThe 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

Secondary

MeasureTime frameDescription
Changes in motor-evoked potential amplitudeimmediately after each intervention session and one-day after all sessionsContinuous measure, the higher the better
Changes in electroencephalography functional connectivityimmediately after each intervention session and one-day after all sessionsContinuous measure, the more significant changes the better
Stability of Motor Imagery featuresimmediately after each intervention session and one-day after all sessionsThe features corresponding to different motor imagery tasks become more stable at the end of the intervention.
More discriminable fMRI activations for different imagined movementsimmediately after each intervention session and one-day after all sessionsThe activation associated with different MI tasks would be more discriminable from BOLD signals. Continuous measure, the more the better.
Change in focality of fMRI activation for different imagined movementsimmediately after each intervention session and one-day after all sessionsThe 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.
Separability of Motor Imagery featuresimmediately after each intervention session and one-day after all sessionsThe features corresponding to different motor imagery tasks become more separable after the intervention.

Countries

United States

Contacts

Primary ContactJose del R. Millan, PhD
jose.millan@austin.utexas.edu512-232-8111
Backup ContactHussein Alawieh
hussein@utexas.edu512-373-0535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026