Non-invasive BCI-controlled Assistive Devices

NCT05183152 | Recruiting FDA Device

• 1 other identifier: 2020030073
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  immediately after each intervention session and up to one week after all sessions

Secondary Outcomes (6)

• Stability of Motor Imagery features

  immediately after each intervention session and one-day after all sessions

• Separability of Motor Imagery features

  immediately after each intervention session and one-day after all sessions

• Changes in motor-evoked potential amplitude

  immediately after each intervention session and one-day after all sessions

• Changes in electroencephalography functional connectivity

  immediately after each intervention session and one-day after all sessions

• Change in focality of fMRI activation for different imagined movements

  immediately after each intervention session and one-day after all sessions

Study Arms (4)

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.

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.

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.

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.

Device: Visual Feedback

Interventions

NMES Feedback DEVICE

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.

NMES BCI - Difficult MI Task

Visual Feedback DEVICE

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.

TESS BCI - Standard MI Task; Visual BCI - Difficult MI Task; Visual BCI - Standard MI Task

TESS DEVICE

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

TESS BCI - Standard MI Task

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Motor Disorders; Spinal Cord Injuries; Muscular Diseases; Motor Neuron Disease; Stroke; Brain Injuries, Traumatic; Movement Disorders; Multiple Sclerosis; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Mental Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Musculoskeletal Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose del R. Millan, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose del R. Millan, PhD

CONTACT

512-232-8111; jose.millan@austin.utexas.edu

Hussein Alawieh

CONTACT

512-373-0535; hussein@utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: BCI Task x Stimulation Modality

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: June 16, 2021
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

US (1)