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Non-invasive BCI-controlled Assistive Devices

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary and study completion dates: Dec 30, 2025 to Dec 30, 2028v7
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Notable Enrollment target: 40 to 100v5 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Interventions: NMES-BCI (Device), Visual-BCI (Device) to NMES Feedback (Device), TESS (Device), Visual Feedback (Device)
    • Secondary endpoints: 3 to 6
    • Study arms: 2 to 4
    • Eligibility criteria shortened, about 1 word
  4. Notable Primary and study completion dates: Dec 30, 2023 to Dec 30, 2025v4
  5. Notable Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Dec 30, 2022 to Dec 30, 2023
    • Site details revised
    v3
  6. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT05183152
Lead Sponsor University of Texas at Austin
Conditions
(from sponsor)
Motor Disorders, Healthy, Spinal Cord Injuries, Muscular Diseases, Motor Neuron Disease, Stroke, Traumatic Brain Injury, Movement Disorders +1 more
Related terms Brain Injuries, Traumatic, Motor Disorders, Motor Neuron Disease, Movement Disorders, Multiple Sclerosis, Muscular Diseases, Neurologic Manifestations, Spinal Cord Injuries, Stroke
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov