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.Study Status:
Recruiting
Disease:
Motor Disorders , Healthy , Spinal Cord Injuries , Muscular Diseases , Motor Neuron Disease , Stroke , Traumatic Brain Injury , Movement Disorders
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
NMES-BCI, Visual-BCI
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Jose del R. Millan, PhD, The University of Texas at Austin
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
The University of Texas at Austin
Jose del R. Millan, PhD / email hidden; JavaScript is required / 512-232-8111
Austin, Texas, 78712 United States
Study Sponsor:
University of Texas at Austin
Estimated Enrollment:
40
Estimated Study Start Date:
06 / 16 / 2021
Estimated Study Completion Date:
12 / 30 / 2023
Posting Last Modified Date:
12 / 05 / 2022
Date Study Added to neals.org:
01 / 10 / 2022
Minimum Age:
18 Years
Maximum Age:
80 Years
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
The University of Texas at Austin | Recruiting
Jose del R. Millan, PhD / 512-232-8111 / email hidden; JavaScript is required
Hussein Alawieh / 5123730535 / email hidden; JavaScript is required
Austin, Texas
78712
United States