Non-invasive BCI-controlled Assistive Devices

Sponsor
University of Texas at Austin (Other)
Overall Status
Recruiting
CT.gov ID
NCT05183152
Collaborator
(none)
40
1
2
18.5
2.2

Study Details

Study Description

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
  • Device: NMES-BCI
  • Device: Visual-BCI
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 16, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Change in the BCI command delivery accuracy [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 [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 [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 [Difference between the week before versus after each intervention]

    Continuous measure, the higher the better

  3. Changes in electroencephalography functional connectivity [Difference between the week before versus after each intervention]

    Continuous measure, the more significant changes the better

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas at Austin Austin Texas United States 78712

Sponsors and Collaborators

  • University of Texas at Austin

Investigators

  • Principal Investigator: Jose del R. Millan, PhD, The University of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT05183152
Other Study ID Numbers:
  • 2020030073
First Posted:
Jan 10, 2022
Last Update Posted:
Jan 10, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2022