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.
2 other identifiers
interventional
17
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2022
CompletedFirst Submitted
Initial submission to the registry
March 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2022
CompletedSeptember 16, 2022
September 1, 2022
4 months
March 9, 2022
September 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Extended use of the LIFT System at home
Through completion of the study, an average of 6 months
Study Arms (1)
Functional task practice and ARC Therapy
EXPERIMENTALFTP and ARC Therapy with the LIFT System at home for 1 month.
Interventions
The LIFT System delivers the Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Craig Hospital
Englewood, Colorado, 80113, United States
Shepherd Center- Crawford Research Institute
Atlanta, Georgia, 30303, United States
INSPIRE Laboratory, Spaulding Hospital
Cambridge, Massachusetts, 02138, United States
University of Minnesota
Minneapolis, Minnesota, 55441, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (3)
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.
PMID: 29877852BACKGROUNDHoffman 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.
PMID: 24244094BACKGROUNDTefertiller 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.
PMID: 41019097DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Candace Tefertiller, PT, DPT, PhD, NCS
Craig Hospital, Colorado, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2022
First Posted
March 17, 2022
Study Start
March 3, 2022
Primary Completion
June 30, 2022
Study Completion
September 13, 2022
Last Updated
September 16, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share