LIFT Home Study of Non-Invasive ARC Therapy for Spinal Cord Injury

Completed · Not applicable

Conditions studied: Chronic Spinal Cord Injury

In brief

The LIFT Home Study is an observational, single-arm study designed to assess the safety of non-invasive electrical spinal stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity functional deficits in people with chronic tetraplegia.

Key facts

Study ID

NCT05284201

Run by

ONWARD Medical, Inc.

People needed

17

Starts

2022-03-03

Expected to finish

2022-09-13

Last updated by the study team

2022-09-16

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, occupational therapist or physical therapist
• Minimum 12 months post-injury
• Capable of providing informed consent
• Completed the Up-LIFT Study within the prior 12 months

You may not qualify if…

• 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
• Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
• Breakdown in skin area that will come into contact with electrodes
• 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
• In the opinion of the investigators, the study is not safe or appropriate for the participant

Where it is running

• Craig Hospital — Englewood, Colorado, United States
• Shepherd Center- Crawford Research Institute — Atlanta, Georgia, United States
• INSPIRE Laboratory, Spaulding Hospital — Cambridge, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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