Clinical trial NCT05284201: LIFT Home Study of Non-Invasive ARC Therapy for Spinal Cord Injury
Official title: Safety and Performance Assessment of the LIFT System When Used to Support Home-based Upper Extremity Training in Individuals With Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Spinal Cord Injury
Keywords: SCI, Tetraplegia, ARC therapy
Lead sponsor: ONWARD Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 17
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The primary goal of this study is to report on the safety of the study device when used at home. In addition, the study will report on observed changes in upper extremity function and strength after a period of home use.

The LIFT Home Study will enroll subjects who have recently completed participation in the Up-LIFT Study. The study includes a set of baseline assessments to be completed in the clinic, a four-week home use treatment program prescribed by the investigator, and a final set of clinic-based assessments at the end of the study.

At the baseline visit, the subject and caregiver will be trained on the use of the device and prescribed a specific training regime for its use at home. The subject will be issued a device that is uniquely programmed to operate within a limited set of parameters as specified by the investigator.

Throughout the study, subjects will be prompted to report all adverse events (AE) regardless of relatedness to the device.

At baseline and the final clinic visit, UE strength and function will be measured with stimulation off using a comprehensive set of assessment tools including CUE-T, GRASSP, Pinch and Grasp Force, as well as patient and caregiver global impression of change questionnaires.

Eligibility criteria: Inclusion Criteria:

1. At least 22 years old and no older than 75 years old at the time of enrollment
2. Non-progressive cervical spinal cord injury from C2-C8 inclusive
3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D
4. Indicated for upper extremity training procedures by subject's treating physician, occupational therapist or physical therapist
5. Minimum 12 months post-injury
6. Capable of providing informed consent
7. Completed the Up-LIFT Study within the prior 12 months

Exclusion Criteria:

1. Has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the Investigator
2. 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
3. Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled
4. Requires ventilator support
5. Has an autoimmune etiology of spinal cord dysfunction/injury
6. Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
7. Breakdown in skin area that will come into contact with electrodes
8. Has any active implanted medical device
9. Pregnant, planning to become pregnant or currently breastfeeding
10. Concurrent participation in another drug or device trial that may interfere with this study
11. In the opinion of the investigators, the study is not safe or appropriate for the participant

Primary outcomes:
measure: Incidence of all adverse events (AEs)
timeFrame: Through completion of the study, an average of 6 months
Secondary outcomes:
measure: Extended use of the LIFT System at home
timeFrame: Through completion of the study, an average of 6 months
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: Atlanta
country: United States
facility: Shepherd Center- Crawford Research Institute
state: Georgia
city: Cambridge
country: United States
facility: INSPIRE Laboratory, Spaulding Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Craig Hospital, Colorado, United States
name: Candace Tefertiller, PT, DPT, PhD, NCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
citation: Hoffman L, Field-Fote E. Effects of practice combined with somatosensory or motor stimulation on hand function in persons with spinal cord injury. Top Spinal Cord Inj Rehabil. 2013 Fall;19(4):288-99. doi: 10.1310/sci1904-288.