Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Device Feasibility for Changing Muscle Activation of the Arm and Hand
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 to use at least one hand due to a spinal cord injury or stroke
- •Individuals that are at least six months from their initial stroke or one year from their initial 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
排除标准
- •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
- •Presence of active cancer at or near the areas of transcutaneous stimulation
- •History of heart or kidney disease
- •History of additional neurologic diseases (e.g., multiple strokes, multiple sclerosis, etc.)
- •Presence of other serious infections, diseases, or disorders that could affect ability to participate in this study (e.g., uncontrolled hypertension, uncontrolled diabetes, rheumatic disease, peripheral neuropathy, HIV or AIDS, etc.)
- •Individuals with a substance abuse (alcoholism or other) problem
- •Pregnant women
- •Prisoners
研究组 & 干预措施
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.
干预措施: Transcutaneous Electrical Stimulation (Device)
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.
干预措施: Transcutaneous Electrical Stimulation (Device)
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.
干预措施: Transcutaneous Electrical Stimulation (Device)
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.
干预措施: Transcutaneous Electrical Stimulation (Device)
结局指标
主要结局
Device Feasibility for Changing Muscle Activation of the Arm and Hand
时间窗: 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).
次要结局
未报告次要终点
研究者
Chad Bouton
Vice President, Advanced Engineering
Northwell Health