Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755699
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2021-01-13
Brief Title:
Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 armhand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional armhand or legfoot 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 limbs andor electrical stimulation to the spinal cord to evoke specified movements The stimulation parameters and locations on the spinal column andor limbs that evoke specific movements will be noted The movements will be assessed with visual inspection electromyography andor 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 individuals participation in the study is considered complete
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 limbs andor electrical stimulation to the spinal cord to evoke specified movements The stimulation parameters and locations on the spinal column andor limbs that evoke specific movements will be noted The movements will be assessed with visual inspection electromyography andor 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 individuals participation in the study is considered complete
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 CupConeBall Transfer All of these tests and exams have been validated and involve participants performing simple movement tasks or identifying a physical sensation
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 CupConeBall Transfer All of these tests and exams have been validated and involve participants performing simple movement tasks or identifying a physical sensation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None