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Non-invasive BCI-controlled Assistive Devices

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05183152
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Texas at Austin
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jose del R. Millan, PhD
Principal Investigator Affiliation	The University of Texas at Austin
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Motor Disorders, Healthy, Spinal Cord Injuries, Muscular Diseases, Motor Neuron Disease, Stroke, Traumatic Brain Injury, Movement Disorders, Multiple Sclerosis

Arms & Interventions

Arms

Experimental: TESS BCI - Standard MI Task

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.

Active Comparator: Visual BCI - Standard MI Task

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.

Experimental: NMES BCI - Difficult MI Task

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.

Active Comparator: Visual BCI - Difficult MI Task

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.

Interventions

Device: - NMES 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.

Device: - Visual Feedback

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.

Device: - TESS

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The University of Texas at Austin, Austin, Texas

Status

Recruiting

Address

The University of Texas at Austin

Austin, Texas, 78712

Site Contact

Jose del R. Millan, PhD

[email protected]

512-232-8111

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