BCI-Controlled Devices for Motor Disorders

Overseen By Jose del R. Millan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: CNS affecting

Disqualifiers: Cognitive deficits, Metabolic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people with motor disorders regain better movement control. It uses brain-computer interfaces (BCIs) to interpret brain signals and control assistive devices, potentially enhancing rehabilitation. The study focuses on two main approaches: using electrical stimulation to boost brain signal stability and distinguishing specific hand movements. It may suit individuals with motor issues from conditions like stroke or spinal cord injuries, who have normal or corrected vision and can read and understand English. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve rehabilitation methods for motor disorders.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes participants on heavy medication affecting the central nervous system. It's best to discuss your specific medications with the trial team.

What prior data suggests that these BCI-controlled devices are safe for motor disorder rehabilitation?

Research has shown that transcutaneous electrical spinal stimulation (TESS) can make spinal nerves more responsive, potentially activating certain nerve pathways. Studies have also explored its role in helping people with spinal cord injuries regain movement. No major negative effects have been reported, suggesting it is generally safe.

For neuromuscular electrical stimulation (NMES), research indicates it can significantly improve movement in stroke patients. It works by sending electrical signals to muscles, aiding in the understanding of motor imagery. Again, studies have not reported serious side effects, suggesting that NMES is generally safe for participants.

Both techniques are under study to assist with brain-computer interface (BCI) training, which enables the brain to control external devices. Past studies suggest that both TESS and NMES show promise for improving movement recovery with minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these brain-computer interface (BCI)-controlled devices for motor disorders because they offer a non-invasive approach to assistive technology. Unlike traditional treatments that might involve medication or surgery, these devices use the power of the mind to control movements through motor imagery. The treatments incorporate innovative feedback methods, such as Transcutaneous Electrical Spinal Stimulation (TESS) and Neuromuscular Electrical Stimulation (NMES), which are thought to enhance the effectiveness of BCI training. This could potentially lead to more effective rehabilitation and improved motor function for individuals with motor disorders, offering a new hope for enhanced quality of life.

What evidence suggests that this trial's BCI-controlled devices could be effective for motor disorders?

This trial will compare different BCI-controlled assistive device training methods. One arm will use transcutaneous electrical spinal stimulation (TESS) before BCI training sessions. Research has shown that TESS can improve movement control by facilitating brain signal transmission to muscles, potentially accelerating the learning of BCI tasks. Specifically, studies have found that just a few TESS sessions can enhance movement and sensation, with effects lasting at least a week.

Another arm will focus on the NMES approach, combining neuromuscular electrical stimulation (NMES) with BCI training. Many studies suggest that this combination can significantly enhance movement abilities. NMES helps distinguish between different imagined movements, improving the use of assistive devices. This combined method has been particularly effective in enhancing movement in stroke patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Jose del R. Millan, PhD

Principal Investigator

The University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for people with certain motor disabilities (like stroke, spinal cord injury, or muscular diseases) and healthy individuals with normal vision. Participants must understand English and be able to consent. Those with serious illnesses, attention/cognitive issues preventing focus during sessions, heavy central nervous system medication, or conditions affecting EEG/EMG data collection can't join.

Inclusion Criteria

Ability to provide informed consent

Able-bodied participants in good general health with normal or corrected vision and no history of neurological/psychiatric disease

Ability to read and understand English (Research Personnel do not speak Spanish)

Exclusion Criteria

You have another serious health condition, like a metabolic disorder.

You have trouble moving and paying attention for the entire study session.

You are taking strong medication that affects your brain and alertness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo BCI training with transcutaneous electrical spinal stimulation and neuromuscular electrical stimulation to improve motor imagery control.

8 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in BCI command delivery performance and SMR modulation strength.

1 week

1 visit (in-person)

Long-term Follow-up

Participants are assessed for stability and separability of motor imagery features and changes in fMRI activations.

1 day after all sessions

What Are the Treatments Tested in This Trial?

Interventions

• Non-invasive BCI-controlled Assistive Devices

Trial Overview The study tests brain-computer interfaces (BCI) that read brain activity to control devices without movement. It focuses on whether neuromuscular electrical stimulation (NMES), when paired with motor imagery-based BCI, improves the differentiation of hand movement patterns in the same limb.

How Is the Trial Designed?

Group I: TESS BCI - Standard MI Task Experimental Treatment 2 Interventions

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.

Group II: NMES BCI - Difficult MI Task Experimental Treatment 1 Intervention

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.

Group III: Visual BCI - Standard MI Task Active Control 1 Intervention

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.

Group IV: Visual BCI - Difficult MI Task Active Control 1 Intervention

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.

Non-invasive BCI-controlled Assistive Devices is already approved in United States, European Union for the following indications:

Approved in United States as Non-invasive BCI-controlled Assistive Devices for:

• Rehabilitation for stroke survivors with chronic motor deficits
• Assistive technology for individuals with severe motor impairments

Approved in European Union as Non-invasive BCI-controlled Assistive Devices for:

• Assistive technology for individuals with spinal cord injuries
• Rehabilitation for individuals with motor impairments

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

Brain-computer interfaces (BCIs) have advanced significantly over the past few decades, leading to the creation of faster and more reliable technologies that help individuals with severe disabilities control external devices using their brain activity.

These developments in BCIs represent a promising area of research and application, enhancing the quality of life for people with disabilities by providing them with new ways to interact with their environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain⁻Computer Interfaces for Human Augmentation. Valeriani, D., Cinel, C., Poli, R.[2020]

A new brain-computer interface (BCI) method using non-invasive EEG signals showed high reliability in classifying motor intentions without requiring extensive training, achieving over 90% accuracy in healthy volunteers and around 80% in patients with neurological disorders.

The study demonstrated that EEG beta band activity, particularly from the sensorimotor area, is effective for distinguishing between motor execution and motor imagery, making this BCI method promising for clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A high performance sensorimotor beta rhythm-based brain-computer interface associated with human natural motor behavior. Bai, O., Lin, P., Vorbach, S., et al.[2022]

Noninvasive brain-computer interfaces (BCIs) using EEG have successfully enabled communication for paralyzed and locked-in patients, demonstrating their potential for clinical applications.

While invasive BCIs in animals have shown promise for precise motor control, it remains unclear if they provide superior benefits over noninvasive methods for restoring voluntary movement in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological regulation of thinking: brain-computer interface (BCI) research. Birbaumer, N., Weber, C., Neuper, C., et al.[2006]

Brain-computer interface (BCI) technology can help individuals with neurological disorders and disabilities by enabling them to communicate and control devices using only their thoughts.

In laboratory experiments, BCIs have successfully allowed patients to perform tasks by imagining movements, showcasing their potential for functional support in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Step Closer to Mind Control for Everyday Life. Bates, M.[2021]

Implantable Brain-Computer Interface (BCI) devices are undergoing clinical trials in the U.S., with potential introduction to Canada in the near future, highlighting the advancements in this technology.

The article argues that BCIs should not be approved for investigational testing in Canada until stronger regulatory safeguards are established to protect research subjects, indicating concerns about safety and oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Computer Interface devices: risks and Canadian regulations. Alpert, S.[2008]

In a study involving 18 healthy untrained subjects, those who practiced distinguishing between a motor imagery task and mental relaxation had better control over a brain-computer interface (BCI) compared to those who only practiced motor imagery tasks.

The findings suggest that effective BCI training protocols should be tailored to individual subjects, emphasizing the importance of selecting easily distinguishable mental tasks to enhance EEG control and user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Training protocol evaluation of a brain-computer interface: mental tasks proposal]. Ron-Angevin, R., Díaz-Estrella, A.[2015]

The integration of brain-computer interface (BCI) technology into the QualiWORLD assistive device showed high effectiveness in communication and internet tasks among four users with severe disabilities, indicating its potential for enhancing user interaction.

Despite high user satisfaction and performance, challenges such as the EEG-cap and low speed were identified, suggesting that further improvements are necessary for practical daily use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brain-computer interface as input channel for a standard assistive technology software. Zickler, C., Riccio, A., Leotta, F., et al.[2017]

A new capacitive EEG electrode, which does not require gel or direct contact with the scalp, showed high performance in brain-computer interface (BCI) systems, achieving an accuracy of 95.2% for visual tasks and 82.6% for auditory tasks in tests with five subjects.

The capacitive electrode demonstrated feasibility for practical use in BCI applications, suggesting it could provide a more user-friendly and non-intrusive alternative to traditional wet electrodes, which require more complex setup and cleanup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-computer interfaces using capacitive measurement of visual or auditory steady-state responses. Baek, HJ., Kim, HS., Heo, J., et al.[2013]

A noninvasive brain-computer interface (BCI) using scalp-recorded brain signals can provide multidimensional movement control for individuals with severe motor disabilities, comparable to invasive BCIs used in monkeys.

The adaptive algorithm in this noninvasive BCI enhances users' ability to control movements by focusing on the brain signals they can best manage, suggesting a safe and effective alternative for operating robotic arms or neuroprostheses without surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of a two-dimensional movement signal by a noninvasive brain-computer interface in humans. Wolpaw, JR., McFarland, DJ.[2023]

The recoveriX system is a novel brain-computer interface designed specifically for stroke patients, aiming to enhance therapy by monitoring motor imagery in real-time.

Initial results from a single patient indicate that recoveriX can provide closed-loop feedback, potentially improving compliance and effectiveness of rehabilitation therapies for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

recoveriX: a new BCI-based technology for persons with stroke. Irimia, D., Sabathiel, N., Ortner, R., et al.[2020]

A chronically implanted ECoG brain-computer interface (BCI) allowed a participant with ALS to achieve a median spelling rate of 10.2 characters per minute using a click-decoding method, demonstrating effective communication capabilities.

The click decoder maintained robust performance over 90 days without retraining, even after being trained on a small dataset of less than 44 minutes, indicating its long-term stability and potential for practical use in communication for individuals with movement and speech impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A click-based electrocorticographic brain-computer interface enables long-term high-performance switch-scan spelling. Crone, N., Candrea, D., Shah, S., et al.[2023]

The study introduces a novel dynamic and self-adaptive algorithm (DSAA) that improves the accuracy of brain-computer interfaces (BCIs) by 8% compared to existing methods, based on experiments with 17 subjects.

DSAA effectively selects the best feature extraction and classification algorithms for each individual during both training and online testing, enhancing the system's performance even without reference labels for trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dynamic and self-adaptive classification algorithm for motor imagery EEG signals. Belwafi, K., Gannouni, S., Aboalsamh, H., et al.[2020]

Non-invasive brain-computer interfaces (BCIs) have the potential to significantly improve communication for patients with severe disabilities, such as those with locked-in syndrome, but they are not yet commonly used in daily life despite some successful individual cases.

Recent advancements in hybrid BCIs, which combine different paradigms and signals, may enhance performance and communication speed, addressing issues like BCI illiteracy and offering more effective solutions for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-paradigm and hybrid brain computing interfaces and their use by disabled patients. de Neeling, M., Van Hulle, MM.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11464471/

The effect of brain-computer interface controlled functional ... Numerous studies have confirmed that BCI-based training significantly improves upper limb motor function in stroke patients and the combination ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11418395/

Effects of motor imagery-based brain-computer interface ... This study aimed to assess the impact of BCI rehabilitation on lower limb motor dysfunction in individuals with acute ischemic stroke.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1388245713002435

Neuromuscular electrical stimulation induced brain ... Neuromuscular electrical stimulation (NMES) induced afferent motor patterns helped classifying motor imagery (MI). •. Offline analyses showed that NMES-based ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0361923025001662

Advances in brain-computer interface controlled functional ... This paper reviews the application of BCI-FES in the recovery of upper limb function after stroke and explores its underlying mechanisms.

5. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/15665

Efficacy of brain-computer interface-driven neuromuscular ... Effectiveness of motor and prefrontal cortical areas for brain-controlled functional electrical stimulation neuromodulation. Journal of Neural ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11922947/

Efficacy and safety of brain–computer interface for stroke ... It has been proven that BCI-combined treatment can improve upper limb motor function and the quality of daily life for stroke patients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03379532

NCT03379532 | BCI-controlled NMES in Subacute Stroke In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to voluntary activation of primary motor cortex ...

8. neals.org neals.org/als-trials/nct05183152

Non-invasive Brain-computer Interfaces for Control of ... In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to the voluntary activation of the primary ...

9. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01588-x

Effects of brain-computer interface based training on post ... Our results showed that BCI-FES, BCI-robot, and BCI-visual feedback can significantly improve motor impairment. These findings underscored ...