Non-invasive Brain-computer Interfaces for Control of Assistive Devices

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS, 

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Jose del R. Millan, PhD The University of Texas at Austin

Clinicaltrials.gov ID (11 digit #):

NCT05183152

Neals Affiliated?

No

Coordinating Center Contact Information

The University of Texas at Austin
Jose del R. Millan, PhD / .(JavaScript must be enabled to view this email address) / 512-232-8111
Hussein Alawieh / .(JavaScript must be enabled to view this email address) / 512-373-0535
Austin, Texas 78712 United States

Full Study Summary:

Study Sponsor:

University of Texas at Austin

Participant Duration:

Estimated Enrollment:

40

Estimated Study Start Date:

06/16/2021

Estimated Study Completion Date:

12/30/2022

Posting Last Modified Date:

05/13/2022

Date Study Added to alsconsortium.org:

05/13/2022
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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

  • Site Contact Information

    The University of Texas at Austin
    Jose del R. Millan, PhD / .(JavaScript must be enabled to view this email address) / 512-232-8111
    Hussein Alawieh / .(JavaScript must be enabled to view this email address) / 512-373-0535
    Austin, Texas 78712
    United States