Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis

Sponsor

Northwell Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT04755699

Collaborator

(none)

Enrollment

Location

Arms

66.9

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers Spinal Cord Injury Stroke Paralysis Paresis Neurological Injury	Device: Transcutaneous Electrical Stimulation	Early Phase 1

Detailed Description

During study sessions, both neuromuscular and spinal cord stimulation will first be manually administered to properly map the area in relation to intended movements. Once mapping for placement is completed, the study team will proceed with administering electrical stimulation with the investigational stimulator to evoke specific movements. In order to facilitate the connectivity of these electrodes with the skin, electroconductive gels, lotions, creams, and sold hydrogels may be used.

The improvement of the precision, specificity, and extent of functional movements over the course of focused electrical stimulation sessions for various electrical stimulation amplitudes at key locations will be assessed visually and through electromyography. The grip strength and evoked pressures at the limbs will also be measured using sensors placed at those locations. The specificity and quantification of the various movements will be assessed with a motion tracking device as well.

The study will use the following clinical tests and graded tasks, as needed, to assess changes in functional movement over time: Range of Movement Evaluation; Spasticity Reduction Evaluation; Sensory Perception Evaluation; Graded Redefined Assessment of Strength, Sensibility, and Prehension; Jebsen-Taylor Test; Action Research Arm Test; Chedoke Arm and Hand Activity Inventory; Chedoke-McMaster Stroke Scale; Wolf Motor Function Test; Just Noticeable Weight Test; Grip Strength / Finger Strength Assessments; Fugl-Meyer Assessment; Stroke Rehabilitation Assessment of Movement; and Object Transfer Tests (including 9-Hole Peg & Cup/Cone/Ball Transfer). All of these tests and exams have been validated, and involve participants performing simple movement tasks or identifying a physical sensation.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study will enroll a total of 28 participants. Of the 28 participants, 7 will be healthy volunteers having no disabilities, 7 will be individuals with paralysis or paresis from a spinal cord injury, 7 will be individuals with paralysis or paresis from a stroke, and 7 will be individuals with paralysis or paresis from other brain or nerve injuries.The study will enroll a total of 28 participants. Of the 28 participants, 7 will be healthy volunteers having no disabilities, 7 will be individuals with paralysis or paresis from a spinal cord injury, 7 will be individuals with paralysis or paresis from a stroke, and 7 will be individuals with paralysis or paresis from other brain or nerve injuries.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis

Actual Study Start Date :

Dec 2, 2020

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Healthy Volunteers This arm consists of healthy volunteers receiving transcutaneous electrical stimulation to the arms, legs, and/or spinal column to evoke various arm/hand and leg/foot movements.	Device: Transcutaneous Electrical Stimulation The 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.
Experimental: Individuals with a Spinal Cord Injury This arm consists of individuals with a spinal cord injury receiving transcutaneous electrical stimulation to the arms/hand and/or spinal column to evoke various arm/hand movements.	Device: Transcutaneous Electrical Stimulation The 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.
Experimental: Individuals with a Stroke This arm consists of individuals with a stroke receiving transcutaneous electrical stimulation to the arms/hand and/or spinal column to evoke various arm/hand movements.	Device: Transcutaneous Electrical Stimulation The 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.
Experimental: Individuals with other Brain or Nerve Injuries This arm consists of individuals with a other brain and nerve injuries receiving transcutaneous electrical stimulation to the arms/hand, legs/foot, and/or spinal column to evoke various arm/hand or leg/foot movements.	Device: Transcutaneous Electrical Stimulation The 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.

Outcome Measures

Primary Outcome Measures

Device Feasibility for Changing Muscle Activation of the Arm and Hand [12 months]
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).

Other Outcome Measures

Change in Muscle Activation of the Targeted Limbs [12 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Healthy Volunteer Inclusion Criteria:

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
Individuals that are willing and able to visit the study center for study procedures, which may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session

Stroke and Spinal Cord Injury Participant Inclusion Criteria:

Individuals between 18 and 75 years of age
Individuals with a limited ability or no ability to use at least one hand due to a spinal cord injury or stroke
Individuals that are at least one year from their initial stroke or spinal cord injury
Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions
Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation
Individuals that are willing and able to visit the study center for study procedures, which may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session

Brain or Nerve Injury Participant Inclusion Criteria:

Individuals between 18 and 75 years of age
Individuals with a limited ability or no ability to use at least one limb due to a brain or nerve injury such as a traumatic brain injury, brachial plexus injury, peripheral nerve damage, or Parkinson's Disease.
Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions
Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation
Individuals that are willing and able to visit the study center for study procedures, which may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session

Exclusion Criteria for All Study Participants:

Individuals participating in another study that may affect the conduct or results of this study
Individuals having or exhibiting any of the following, as specified by self-report:
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)
Abnormalities of the arms/hands, legs/feet, or spinal column that would prevent electrical stimulation
Ventilator dependence
History of serious mood or thought disorder
Uncontrolled autonomic dysreflexia
Severe spasticity in extremities of interest that are uncontrolled by pharmacological methods or prevents electrical stimulation
Botulinum toxin injections to the extremity of interest within 3 months
Individuals with a substance abuse (alcoholism or other) problem
Pregnant women
Prisoners