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Non-invasive BCI-controlled Assistive Devices

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ClinicalTrials.gov Identifier: NCT05183152
Recruitment Status : Recruiting
First Posted : January 10, 2022
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

Study Description
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Brief Summary:
A brain-computer interface (BCI) decodes users' behavioral intentions or mental states directly from their brain activity, thus allowing operation of devices without requiring any overt motor action. One major modality for BCI control is based on motor imagery (MI), which is the mental rehearsal of the kinesthetics of a movement without actually performing it. MI-based BCIs translate motor intents into control commands for external devices. A major challenge in such BCIs is differentiating MI patterns corresponding to fine hand movements of the same limb from non-invasive EEG recordings with low spatial resolution since the cortical sources responsible for these movements are overlapping. In this study, 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. This is expected to be associated with neuroplastic changes at the cortical or corticospinal levels.

Condition or disease Intervention/treatment Phase
Motor Disorders Healthy Spinal Cord Injuries Muscular Diseases Motor Neuron Disease Stroke Traumatic Brain Injury Movement Disorders Device: NMES-BCI Device: Visual-BCI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Brain-computer Interfaces for Control of Assistive Devices
Actual Study Start Date : June 16, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NMES-BCI
Sensory-threshold electrical stimulation is delivered to the flexors/extensors of the forearm contingent to the voluntary activation of the motor cortex by motor imagery of hand flexion/extension as detected by a closed-loop BCI.
 Device: NMES-BCI
Electroenceauphalography (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.
Active Comparator: Visual-BCI
Bar-based visual feedback is provided on a screen contingent to the voluntary activation of the motor cortex by motor imagery of hand flexion/extension as detected by a closed-loop BCI.
 Device: Visual-BCI
Electroenceauphalography (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 control the right/left movement of a bar on a computer screen. The bar feedback is contingent to the detection of a subject-specific flexion/extension EEG patterns.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the BCI command delivery accuracy [ Time Frame: Difference between the week before versus after each intervention ]
    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.

  2. Change in fMRI activation for different imagined movements [ Time Frame: Difference between the week before versus after each intervention ]
    • The clusters of significant activation during MI of different movements would be more separable
    • The activation associated with different MI tasks would be more discriminable


Secondary Outcome Measures :
  1. Stability and separability of Motor Imagery features [ Time Frame: Difference between the week before versus after each intervention ]
    The features corresponding to different motor imagery tasks become more separable and are more stable at the end of the intervention.

  2. Changes in motor-evoked potential amplitude [ Time Frame: Difference between the week before versus after each intervention ]
    Continuous measure, the higher the better

  3. Changes in electroencephalography functional connectivity [ Time Frame: Difference between the week before versus after each intervention ]
    Continuous measure, the more significant changes the better


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 (Research Personnel do not speak Spanish)
  • ability to provide informed consent

Exclusion Criteria:

  • Subjects with motor disabilities
  • short attentional spans or cognitive deficits that prevent to remain concentrated 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 FES/tdCS/tACS delivery (e.g., skin infection, wounds, dermatitis, metal implants under electrodes)
  • criteria identified in safety guidelines for MRI and TMS, in particular metallic implants
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05183152


Contacts
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Contact: Jose del R. Millan, PhD 512-232-8111 jose.millan@austin.utexas.edu
Contact: Hussein Alawieh 512-373-0535 hussein@utexas.edu

Locations
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United States, Texas
The University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Jose del R. Millan, PhD    512-232-8111    jose.millan@austin.utexas.edu   
Contact: Hussein Alawieh    5123730535    hussein@utexas.edu   
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Jose del R. Millan, PhD The University of Texas at Austin
More Information
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Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT05183152    
Other Study ID Numbers: 2020030073
First Posted: January 10, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Texas at Austin:
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
Additional relevant MeSH terms:
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Muscular Diseases
Brain Injuries
Spinal Cord Injuries
Brain Injuries, Traumatic
Movement Disorders
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Disease
Wounds and Injuries
Motor Disorders
Pathologic Processes
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Mental Disorders
Musculoskeletal Diseases