Evaluating Neuromuscular Stimulation for Restoring Hand Movements
Condition: Healthy Volunteers; Spinal Cord Injury Cervical; Physical and Rehabilitation Medicine
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.
Intervention type(s): Device
Intervention description(s): The study involves the administration of various electrical pulses being delivered to muscles of the forearm from a neuromuscular stimulator in order to evoke different hand and finger movements. The grip strength and evoked forces at the fingertips will also be measured using sensors.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
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.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Physical and Rehabilitation Medicine; Transcutaneous Electrical Nerve Stimulation; Healthy Volunteer; Spinal Cord Injury; Biomedical Engineering