search
Back to results

Non-invasive BCI-controlled Assistive Devices

Primary Purpose

Motor Disorders, Healthy, Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NMES-BCI
Visual-BCI
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motor Disorders focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NMES-BCI

Visual-BCI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the BCI command delivery accuracy
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
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

Stability and separability of Motor Imagery features
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
Continuous measure, the higher the better
Changes in electroencephalography functional connectivity
Continuous measure, the more significant changes the better

Full Information

First Posted
December 20, 2021
Last Updated
December 1, 2022
Sponsor
University of Texas at Austin
search

1. Study Identification

Unique Protocol Identification Number
NCT05183152
Brief Title
Non-invasive BCI-controlled Assistive Devices
Official Title
Non-invasive Brain-computer Interfaces for Control of Assistive Devices
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Disorders, Healthy, Spinal Cord Injuries, Muscular Diseases, Motor Neuron Disease, Stroke, Traumatic Brain Injury, Movement Disorders
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMES-BCI
Arm Type
Experimental
Arm Description
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.
Arm Title
Visual-BCI
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
NMES-BCI
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Visual-BCI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the BCI command delivery accuracy
Description
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.
Time Frame
Difference between the week before versus after each intervention
Title
Change in fMRI activation for different imagined movements
Description
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
Time Frame
Difference between the week before versus after each intervention
Secondary Outcome Measure Information:
Title
Stability and separability of Motor Imagery features
Description
The features corresponding to different motor imagery tasks become more separable and are more stable at the end of the intervention.
Time Frame
Difference between the week before versus after each intervention
Title
Changes in motor-evoked potential amplitude
Description
Continuous measure, the higher the better
Time Frame
Difference between the week before versus after each intervention
Title
Changes in electroencephalography functional connectivity
Description
Continuous measure, the more significant changes the better
Time Frame
Difference between the week before versus after each intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose del R. Millan, PhD
Phone
512-232-8111
Email
jose.millan@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hussein Alawieh
Phone
512-373-0535
Email
hussein@utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose del R. Millan, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose del R. Millan, PhD
Phone
512-232-8111
Email
jose.millan@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Hussein Alawieh
Phone
5123730535
Email
hussein@utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
All data will be made available by the online publication date
IPD Sharing Access Criteria
Data will be placed in public servers for any interested researcher to access it

Learn more about this trial

Non-invasive BCI-controlled Assistive Devices

We'll reach out to this number within 24 hrs