The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury (Up-LIFT)

Overview

About this study

The purpose of this study is to provide confirmatory evidence that use of the LIFT System, inclusive of all components and accessories, is safe; to provide confirmatory evidence that use of the LIFT System provides an effective treatment for the restoration or improvement in UE strength and function; and to provide data regarding the potential benefits of the LIFT System to achieve other secondary outcomes such as improvement in pain, spasticity, quality of life, cardiovascular (blood pressure) and autonomic function.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • At least 22 years old and no older than 75 years old at the time of enrollment.
  • Non-progressive cervical spinal cord injury from C2-C8 inclusive.
  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
  • Indicated for upper extremity training procedures by subject's treating physician or a physical therapist.
  • Baseline GRASSP-Prehension score ≥ 10 or GRASSP-Strength score ≥ 30.
  • Minimum 12 months post-injury.
  • Titration of baclofen to 10 mg or less at night.
  • On stable spasticity and pain medications for at least 4 weeks prior to enrollment.
  • Capable of providing informed consent.

Exclusion Criteria:

  • Has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the Investigator.
  • Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations like severe neuropathic pain, depression, mood disorders or other cognitive disorders.
  • Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
  • Requires ventilator support.
  • Has an autoimmune etiology of spinal cord dysfunction/injury.
  • Previously diagnosed as having transverse myelitis.
  • History of additional neurologic disease such as stroke, multiple sclerosis, traumatic brain injury, etc.
  • Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
  • Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator.
  • Received Botulinum toxin injections in their upper extremity, neck or hand within 6 months prior to enrollment.
  • Has painful musculoskeletal dysfunction unrelated to SCI, unhealed fracture, contracture, pressure sore, or urinary tract infection at time of enrollment.
  • Breakdown in skin area that will come into contact with electrodes.
  • Presence of syringomyelia as confirmed by an MRI.
  • Currently undergoing treatment for cancer or has been in remission for less than 2 years.
  • Received stem cell treatment within the past two years prior to enrollment.
  • Has any active implanted medical device.
  • Pregnant, planning to become pregnant or currently breastfeeding.
  • Concurrent participation in another drug or device trial that may interfere with this study.
  • Has undergone a prior course of NESS therapy directed at UE improvement.
  • In the opinion of the investigators, the study is not safe or appropriate for the participant.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kristin Zhao, Ph.D.

Closed for enrollment

Contact information:

Julie Block

(507) 255-7393

Block.Julie@mayo.edu

More information

Publications

  • Upper extremity function is the highest priority of tetraplegics for improving quality of life. We aim to determine the therapeutic potential of transcutaneous electrical spinal cord stimulation for restoration of upper extremity function. We tested the hypothesis that cervical stimulation can facilitate neuroplasticity that results in long-lasting improvement in motor control. A 62-year-old male with C3, incomplete, chronic spinal cord injury (SCI) participated in the study. The intervention comprised three alternating periods: 1) transcutaneous spinal stimulation combined with physical therapy (PT); 2) identical PT only; and 3) a brief combination of stimulation and PT once again. Following four weeks of combined stimulation and physical therapy training, all of the following outcome measurements improved: the Graded Redefined Assessment of Strength, Sensation, and Prehension test score increased 52 points and upper extremity motor score improved 10 points. Pinch strength increased 2- to 7-fold in left and right hands, respectively. Sensation recovered on trunk dermatomes, and overall neurologic level of injury improved from C3 to C4. Most notably, functional gains persisted for over 3 month follow-up without further treatment. These data suggest that noninvasive electrical stimulation of spinal networks can promote neuroplasticity and long-term recovery following SCI. Read More on PubMed
  • Individuals with chronic tetraplegia prioritize recovery of hand function as an important factor in improving their quality of life. Interventions that may improve hand function and increase corticomotor excitability are functional electrical stimulation (FES), somatosensory stimulation (SS), and task-oriented training. Read More on PubMed
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CLS-20508800

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