Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNorthwell Health
About this trial
This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm/hand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm/hand or leg/foot movements in individuals with paralysis or paresis due to other brain or nerve injuries.
In this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities.
During subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and/or electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and/or limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and/or sensors.
The clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals between 18 and 75 years of age
Individuals without physical disabilities or conditions/diseases that may make them incapable of completing the physical study tasks or otherwise places them at a greater risk of harm
Individuals that are considered English Proficient due to the study requirements to follow verbal commands during sessions
Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation
Disqualifiers
Individuals participating in another study that may affect the conduct or results of this study
Stage III-IV pressure ulcers that adversely interfere with study involvement (i.e., pressure ulcer on the extremity of interest or prohibits extended bouts of sitting)
History of epilepsy
Chronically-implanted electronic medical device (e.g. deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Electrical Stimulation
DeviceThe study involves the administration of various electrical pulses being delivered to muscles and/or the spinal column with an investigational neurostimulator to evoke various limb movements in order to improve functional movement.
Treatment groups
64 Participants
are divided into 4 treatment groupsGroup A: Healthy VolunteersActive comparator 1 intervention
Group B: Individuals with a Spinal Cord InjuryExperimental treatment 1 intervention
Group C: Individuals with a StrokeExperimental treatment 1 intervention
Group D: Individuals with other Brain or Nerve InjuriesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device Feasibility for Changing Muscle Activation of the Arm and Hand
The primary outcome will be measured as the ability for the neurostimulation device to elicit changes in muscle activation (measured by electromyography) of the arm and hand of individuals with a spinal cord injury or stroke from baseline (prior to study intervention) until study completion (after initiation of study intervention).
Time frame
12 monthsOther outcomes
1
Change in Muscle Activation of the Targeted Limbs
The exploratory outcome will be measured as the change in muscle activation (measured by electromyography) of the targeted limbs of individuals with other brain or neurological injuries from baseline (prior to study intervention) until study completion (after initiation of study intervention).
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov