Clinical trial NCT05183152: Non-invasive BCI-controlled Assistive Devices
Official title: Non-invasive Brain-computer Interfaces for Control of Assistive Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: BCI Task x Stimulation Modality
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change in the BCI command delivery performance
timeFrame: immediately after each intervention session and up to one week after all sessions
measure: Change in the focality and Strength of SMR Modulation
timeFrame: immediately after each intervention session and up to one week after all sessions
Secondary outcomes:
measure: Stability of Motor Imagery features
timeFrame: immediately after each intervention session and one-day after all sessions
measure: Separability of Motor Imagery features
timeFrame: immediately after each intervention session and one-day after all sessions
measure: Changes in motor-evoked potential amplitude
timeFrame: immediately after each intervention session and one-day after all sessions
measure: Changes in electroencephalography functional connectivity
timeFrame: immediately after each intervention session and one-day after all sessions
measure: Change in focality of fMRI activation for different imagined movements
timeFrame: immediately after each intervention session and one-day after all sessions
measure: More discriminable fMRI activations for different imagined movements
timeFrame: immediately after each intervention session and one-day after all sessions
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Jose del R. Millan, PhD
role: PRINCIPAL_INVESTIGATOR
References: