Motor DisordersNCT05183152
Non-invasive BCI-controlled Assistive Devices
A study testing NMES Feedback, Visual Feedback and TESS in people with Motor Disorders and Healthy, run by University of Texas at Austin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Disorders, Healthy, Spinal Cord Injuries
- What is being tested?
- NMES Feedback, Visual Feedback and TESS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2021to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78712
Jose del R. Millan, PhD, 512-232-8111, jose.millan@austin.utexas.edu
Hussein Alawieh, 5123730535, hussein@utexas.edu
About this study
Official title: Non-invasive Brain-computer Interfaces for Control of Assistive Devices
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.
- Conditions
- Motor Disorders, Healthy, Spinal Cord Injuries, Muscular Diseases, Motor Neuron Disease, Stroke
- Being tested
- NMES Feedback, Visual Feedback, TESS
- 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
- Medical subject headings
- Motor Disorders, Spinal Cord Injuries, Muscular Diseases, Motor Neuron Disease, Stroke, Brain Injuries, Traumatic, Movement Disorders, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES FeedbackDevice
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 FeedbackDevice
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.
TESSDevice
Transcutaneous Electrical Spinal Stimulation (TESS) is applied over the C5-C6 spinal segment for 20 minutes at 30Hz with 5kHz carrier frequency.
| Study group | Role | What they receive |
|---|---|---|
| TESS BCI - Standard MI Task | Experimental | 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. Receives: Device: Visual Feedback; Device: TESS |
| Visual BCI - Standard MI Task | Active comparator | 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. Receives: Device: Visual Feedback |
| NMES BCI - Difficult MI Task | Experimental | 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. Receives: Device: NMES Feedback |
| Visual BCI - Difficult MI Task | Active comparator | 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. Receives: Device: Visual Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: immediately after each intervention session and up to one week after all sessions
Secondary outcomes (6)
Stability of Motor Imagery features
The features corresponding to different motor imagery tasks become more stable at the end of the intervention.
Measured: 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.
Measured: immediately after each intervention session and one-day after all sessions
Changes in motor-evoked potential amplitude
Continuous measure, the higher the better
Measured: immediately after each intervention session and one-day after all sessions
Changes in electroencephalography functional connectivity
Continuous measure, the more significant changes the better
Measured: 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.
Measured: 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.
Measured: immediately after each intervention session and one-day after all sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start16 Jun 2021
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- BCI Task x Stimulation Modality
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose del R. Millan, University of Texas at Austin
- Investigators
- Jose del R. Millan, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183152
- Sponsor's protocol ID
- 2020030073
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain-computer Interfaces for Control of Assistive Devices
- ClinicalTrials.gov ID
- NCT05183152
- Acronym / sponsor ID
- 2020030073
- Conditions
- Motor Disorders, Healthy, Spinal Cord Injuries, Muscular Diseases, Motor Neuron Disease, Stroke
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- BCI Task x Stimulation Modality
| Arm | Type | Receives |
|---|---|---|
| TESS BCI - Standard MI Task | Experimental | Device: Visual Feedback, Device: TESSTranscutaneous 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. |
| Visual BCI - Standard MI Task | Active comparator | Device: Visual FeedbackConventional BCI training is performed with visual feedback contingent to the imagination of right versus left hand movements as detected by a closed-loop BCI. |
| NMES BCI - Difficult MI Task | Experimental | Device: NMES FeedbackBCI 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. |
| Visual BCI - Difficult MI Task | Active comparator | Device: Visual FeedbackConventional 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able-bodied participants:
- Subjects with motor disabilities
Key exclusion criteria (7 listed)
- Subjects with motor disabilities
- All participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMES FeedbackElectroencephalography (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. | Device | NMES BCI - Difficult MI Task |
| Visual FeedbackElectroencephalography (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. | Device | TESS BCI - Standard MI Task, Visual BCI - Difficult MI Task, Visual BCI - Standard MI Task |
| TESSTranscutaneous Electrical Spinal Stimulation (TESS) is applied over the C5-C6 spinal segment for 20 minutes at 30Hz with 5kHz carrier frequency. | Device | TESS BCI - Standard MI Task |
Primary outcome
Change in the BCI command delivery performance
Time frame: immediately after each intervention session and up to one week after all sessions
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.
Change in the focality and Strength of SMR Modulation
Time frame: immediately after each intervention session and up to one week after all sessions
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
6 secondary outcomes
Stability of Motor Imagery features
Time frame: immediately after each intervention session and one-day after all sessions
Separability of Motor Imagery features
Time frame: immediately after each intervention session and one-day after all sessions
Changes in motor-evoked potential amplitude
Time frame: immediately after each intervention session and one-day after all sessions
Changes in electroencephalography functional connectivity
Time frame: immediately after each intervention session and one-day after all sessions
Change in focality of fMRI activation for different imagined movements
Time frame: immediately after each intervention session and one-day after all sessions
More discriminable fMRI activations for different imagined movements
Time frame: immediately after each intervention session and one-day after all sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose del R. Millan, PhD principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES Feedback, Visual Feedback and TESS in people with Motor Disorders and Healthy, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose del R. Millan, PhD (512-232-8111, jose.millan@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the BCI command delivery performance (time frame: immediately after each intervention session and up to one week after all sessions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.