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

NCT ID: NCT05284201

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2022-09-13

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.

Conditions

Chronic Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Functional task practice and ARC Therapy

FTP and ARC Therapy with the LIFT System at home for 1 month.

Group Type: EXPERIMENTAL

LIFT System

Intervention Type: DEVICE

The LIFT System delivers the Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia.

Interventions

LIFT System

The LIFT System delivers the Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ONWARD Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Candace Tefertiller, PT, DPT, PhD, NCS

Role: PRINCIPAL_INVESTIGATOR

Craig Hospital, Colorado, United States

Locations

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29877852 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24244094 (View on PubMed)

Tefertiller C, Trumbower RD, Morse L, Pradarelli J, Gelenitis K, D'Amico JM, Moritz C, Field-Fote EC. Home-Based Noninvasive Spinal Cord Stimulation Safely Enhances Hand and Arm Function in People With Spinal Cord Injury. Neurol Clin Pract. 2025 Dec;15(6):e200537. doi: 10.1212/CPJ.0000000000200537. Epub 2025 Sep 24.

Reference Type: DERIVED

PMID: 41019097 (View on PubMed)

Other Identifiers

Pro00059716

Identifier Type: OTHER

Identifier Source: secondary_id

DOC2530

Identifier Type: -

Identifier Source: org_study_id