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

Safety and Performance Assessment of the LIFT System When Used to Support Home-based Upper Extremity Training in Individuals With Spinal Cord Injury.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Spinal Cord Injury
• Intervention / Treatment: Device: LIFT System

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Craig Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Shepherd Center- Crawford Research Institute
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • INSPIRE Laboratory, Spaulding Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55441
      • University of Minnesota
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional task practice and ARC Therapy; FTP and ARC Therapy with the LIFT System at home for 1 month.	Device: LIFT System; The LIFT System delivers the Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all adverse events (AEs)	Observational data regarding the incidence of all adverse events related to the use of the study device and treatment procedures will be reported.	Through completion of the study, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extended use of the LIFT System at home	The secondary outcome measure will report on the potential for extended use of the LIFT System at home to sustain or advance performance gains achieved during the prior in-clinic treatment phase. Upper extremity performance will be assessed using the CUE-T, GRASSP, Pinch and Grasp Force assessments and the Global Impression of Change questionnaire.	Through completion of the study, an average of 6 months

Collaborators and Investigators

• Sponsor: ONWARD Medical, Inc.
• Investigators: Principal Investigator: Candace Tefertiller, PT, DPT, PhD, NCS, Craig Hospital, Colorado, United States

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: SCI, Tetraplegia, ARC therapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: DOC2530; Pro00059716 (Other Identifier: Advarra)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No