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Suspended
NCT04661891
Real-time Neuromuscular Control of Exoskeletons
Conditions: Stroke
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 80
Sponsor: Shirley Ryan AbilityLab
Location: Shirley Ryan AbilityLab Chicago Illinois
Summary
The purpose of this study is to develop a real-time controller for exoskeletons using neural information embedded in human musculature. This controller will consist of an online interface that anticipates human movement based on high-density electromyography (HD-EMG) recordings, and then translates it into functional assistance. This study will be carried out in both healthy participants and participants post-stroke.
The researchers will develop an online algorithm (decoder) in currently existing exoskeletons that can extract hundreds of motor unit (MU) spiking activity out of HD-EMG recordings. The MU spiking activity is a train of action potentials coded by its timing of occurrence that gives access to a representative part of the neural code of human movement. The researchers will also develop a command encoder that can anticipate human intent (multi-joint position and force commands) from MU spiking activity to translate the neural information to movement. The researchers will integrate the decoder with the command encoder to showcase the real-time control of multiple joint lower-limb exoskeletons.
Eligibility Criteria
Inclusion Criteria for Healthy Participants:
* Age from 18 to 80 years
* No history of a brain and/or skull lesion
* Normal hearing and vision, both can be corrected
* Able to understand and give informed consent
* No neurological disorders
* Absence of pathology that could cause abnormal movements of extremities (e.g.,
* epilepsy, stroke, marked arthritis, chronic pain, musculoskeletal injuries)
* Able to understand and speak English
* Height between 3 foot 6 inches (1.1 meters) and 6 foot 9 inches (2.1 meters)
Inclusion Criteria for Participants Post-stroke:
* Age from 18 to 80 years
* History of unilateral, supratentorial, ischemic or hemorrhage stroke greater than 6 months
* Ability to walk independently on level ground, allowed to use assistive device or bracing
* as needed
* Medically stable
* No planned surgeries, medical treatments or outpatient therapy during the study period
* Normal hearing and vision, both can be corrected
* Able to understand and give informed consent
* Able to understand and speak English
* Height between 3 foot 6 inches (1.1 meters) and 6 foot 9 inches (2.1 meters)
Exclusion Criteria for Healthy Participants:
* Weight over 220 lbs
* Pregnancy (ruled out by pregnancy questionnaire)
* Any neurological diagnoses or medications influencing brain function
* History of significant head trauma (i.e., extended loss of consciousness, neurological
* sequelae)
* Known structural brain lesion
* Significant other disease (heart disease, malignant tumors, mental disorders)
* Non prescribed drug use (as reported by subject)
* History of current substance abuse (exception: current nicotine use is allowed)
* Recreational marijuana
* Dementia; severe depression; or prior neurosurgical procedures
* Failure to perform the behavioral or locomotor tasks
* Prisoners
Exclusion Criteria for Participants Post-Stroke:
* Weight over 220 lbs
* Pregnancy (ruled out by pregnancy questionnaire)
* Botox (botulinum toxin) injection to lower limbs within the prior 3 months, or planned
* injection during study period.
* History of current substance abuse (exception: current nicotine use is allowed)
* Reduced cognitive function
* Severe aphasia
* Prisoners
* Co-existence of other neurological diseases (ex: (Parkinson's disease, traumatic brain
* injury, multiple sclerosis, etc.)
* Mixed or complex tremors
* Severe hip, or knee arthritis
* Osteoporosis (as reported by subject)
* Medical (cardiac, renal, hepatic, oncological) or psychiatric disease that would
* interfere with study procedures for HD-EMG
Source: ClinicalTrials.gov (NCT04661891). StuddyBuddy aggregates publicly available trial information.