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

Study Overview
=================
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.

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.

Conditions
-----------------
Chronic Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: LIFT System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCI, Tetraplegia, ARC therapy