Clinical trial NCT03385005: Evaluating Neuromuscular Stimulation for Restoring Hand Movements
Official title: Evaluating Neuromuscular Stimulation for Restoring Hand Movements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Spinal Cord Injury Cervical
Physical and Rehabilitation Medicine
Keywords: Physical and Rehabilitation Medicine
Transcutaneous Electrical Nerve Stimulation
Healthy Volunteer
Spinal Cord Injury
Biomedical Engineering
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study will involve 3-10 eligible healthy volunteers and 2-5 eligible individuals with a stable cervical spinal cord injury. The study will first enroll healthy volunteers into the study in order to determine the feasibility of evoking refined hand movements through electrical stimulation, and determine the electrical stimulation parameters and electrode spatial configurations responsible for various hand movements. After this is done, the study will proceed with the enrollment of individuals with spinal cord injuries. This enrollment process is being done to reduce the participation time required for participants with a spinal cord injury, and thus lower the likelihood of risks that are more prevalent among individuals with a spinal cord injury.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The specific aim of this study is to evoke functional movement in the hand of both healthy individuals and individuals diagnosed with a stable cervical spinal cord injury with non-functional movement of the fingers. The primary purpose of this study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm. It is believed that this study will be able to identify specific stimulation parameters and electrode spatial configurations responsible for various refined hand movements.

After an eligible individual agrees to participate in this study, s/he will receive transcutaneous electrical stimulation on the forearm in order to evoke different hand and finger movements. The precision, specificity, and extent of these movements will be visually assessed. In order to better evaluate these movements, participants may also be asked to perform various functional tasks with their hand. The grip strength and evoked forces at the fingertips will also be measured using sensors. There will be up to 4 study sessions each week for up to 8 weeks, with each session lasting up to 4 hours. Upon completion of these study sessions, the individual's participation in the study is considered complete.

Detailed description: In order to evaluate whether electrical stimulation applied to the muscles within the forearm can evoke functional movement in the hand, participants will receive transcutaneous electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.

Participants will be asked to attend up to 4 study sessions a week for up to 8 weeks, with each session lasting up to 4 hours. At these sessions, electrical pulses will be sent to the forearm muscles through electrodes placed on the skin. These electrodes may also be accompanied with a gel or lotion to allow for a better connection of the electrodes to the skin. The precision, specificity, and extent of hand and finger movements will be visually assessed in real time and later reassessed on video recordings of the session. The study will also involve the placement of sensors on the hand and finger to measure the amount of grip strength and evoked forces. In order to monitor the health of participants, the study will assess blood pressure and heart rate before, during, and after the electrical stimulation. Upon completion of these study sessions, the individual's participation in the study is considered complete.

Eligibility criteria: Inclusion Criteria for Health Volunteers:

* Individuals between 18 and 65 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 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 will be up to 4 sessions a week for up to 8 weeks at up to 4 hours per session
* Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
* Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb

Exclusion Criteria for Healthy Volunteers:

* Individuals participating in another research study that may affect the conduct or results of this study
* Individuals having or exhibiting any of the following:

  * Stage III-IV pressure ulcers
  * Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
  * Prior tendon transfer to enhance hand function
  * History of autoimmune disease
  * Cancer
  * Biochemical abnormalities of the liver, kidney, or pancreas
  * Prior difficulties or allergy to general anesthesia
  * Ventilator dependence
  * History of serious mood or thought disorder
  * Significant residual clinically evident traumatic brain injury or cognitive impairment
  * Uncontrolled autonomic dysreflexia
  * Spasticity in the upper extremities that is uncontrolled by pharmacological methods
* Individuals with a substance abuse (alcoholism or other) problem
* Pregnant women
* Prisoners

Inclusion Criteria for Participants with a Spinal Cord Injury:

* Individuals between 18 and 65 years of age
* Individuals with a stable cervical spinal cord injury with ISNCSCI motor scores for fingers of 0 - 2 (non-functional), and at least one year from 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 will be up to 4 sessions a week for up to 8 weeks at up to 4 hours per session
* Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
* Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb (as expected for a person at their stage of time post spinal cord injury)

Exclusion Criteria for Participants with a Spinal Cord Injury:

* Individuals participating in another research study that may affect the conduct or results of this study
* Individuals having or exhibiting any of the following:

  * Stage III-IV pressure ulcers
  * Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
  * Prior tendon transfer to enhance hand function
  * History of autoimmune disease
  * Cancer
  * Biochemical abnormalities of the liver, kidney, or pancreas
  * Prior difficulties or allergy to general anesthesia
  * Ventilator dependence
  * History of serious mood or thought disorder
  * Significant residual clinically evident traumatic brain injury or cognitive impairment
  * Uncontrolled autonomic dysreflexia
  * Spasticity in the upper extremities that is uncontrolled by pharmacological methods
* Individuals with a substance abuse (alcoholism or other) problem
* Pregnant women
* Prisoners

Primary outcomes:
measure: The primary outcome of the study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm, as assessed by visual inspection.
timeFrame: This outcome measure will be assessed at each study session throughout the 8-week duration of the study.
measure: The primary outcome of the study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm, as assessed by force sensors.
timeFrame: This outcome measure will be assessed at each study session throughout the 8-week duration of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Northwell Health's The Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Chad E Bouton, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouton CE, Shaikhouni A, Annetta NV, Bockbrader MA, Friedenberg DA, Nielson DM, Sharma G, Sederberg PB, Glenn BC, Mysiw WJ, Morgan AG, Deogaonkar M, Rezai AR. Restoring cortical control of functional movement in a human with quadriplegia. Nature. 2016 May 12;533(7602):247-50. doi: 10.1038/nature17435. Epub 2016 Apr 13.
citation: Bhagat N, King K, Ramdeo R, Stein A, Bouton C. Determining grasp selection from arm trajectories via deep learning to enable functional hand movement in tetraplegia. Bioelectron Med. 2020 Aug 25;6:17. doi: 10.1186/s42234-020-00053-5. eCollection 2020.
citation: Ciancibello J, King K, Meghrazi MA, Padmanaban S, Levy T, Ramdeo R, Straka M, Bouton C. Closed-loop neuromuscular electrical stimulation using feedforward-feedback control and textile electrodes to regulate grasp force in quadriplegia. Bioelectron Med. 2019 Nov 1;5:19. doi: 10.1186/s42234-019-0034-y. eCollection 2019.