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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

Tracking Information
First Submitted Date  ICMJE December 20, 2021
First Posted Date  ICMJE January 10, 2022
Last Update Posted Date December 5, 2022
Actual Study Start Date  ICMJE June 16, 2021
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2021)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2021)
  • 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.
  • Changes in motor-evoked potential amplitude [ Time Frame: Difference between the week before versus after each intervention ]
    Continuous measure, the higher the better
  • Changes in electroencephalography functional connectivity [ Time Frame: Difference between the week before versus after each intervention ]
    Continuous measure, the more significant changes the better
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-invasive BCI-controlled Assistive Devices
Official Title  ICMJE Non-invasive Brain-computer Interfaces for Control of Assistive Devices
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Motor Disorders
  • Healthy
  • Spinal Cord Injuries
  • Muscular Diseases
  • Motor Neuron Disease
  • Stroke
  • Traumatic Brain Injury
  • Movement Disorders
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: NMES-BCI
  • 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.
    Intervention: Device: Visual-BCI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2021)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jose del R. Millan, PhD 512-232-8111 jose.millan@austin.utexas.edu
Contact: Hussein Alawieh 512-373-0535 hussein@utexas.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05183152
Other Study ID Numbers  ICMJE 2020030073
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
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
Current Responsible Party University of Texas at Austin
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Texas at Austin
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose del R. Millan, PhD The University of Texas at Austin
PRS Account University of Texas at Austin
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP