Back to resultsLIFT Home Study of Non-Invasive ARC Therapy for Spinal Cord Injury
Primary Purpose
Chronic Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LIFT System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spinal Cord Injury focused on measuring SCI, Tetraplegia, ARC therapy
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
Sites / Locations
- Craig Hospital
- Shepherd Center- Crawford Research Institute
- INSPIRE Laboratory, Spaulding Hospital
- University of Minnesota
- University of Washington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Functional task practice and ARC Therapy
Arm Description
FTP and ARC Therapy with the LIFT System at home for 1 month.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05284201
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ONWARD Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spinal Cord Injury
Keywords
SCI, Tetraplegia, ARC therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional task practice and ARC Therapy
Arm Type
Experimental
Arm Description
FTP and ARC Therapy with the LIFT System at home for 1 month.
Intervention Type
Device
Intervention Name(s)
LIFT System
Intervention Description
The LIFT System delivers the Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia.
Primary Outcome Measure Information:
Title
Incidence of all adverse events (AEs)
Description
Observational data regarding the incidence of all adverse events related to the use of the study device and treatment procedures will be reported.
Time Frame
Through completion of the study, an average of 6 months
Secondary Outcome Measure Information:
Title
Extended use of the LIFT System at home
Description
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.
Time Frame
Through completion of the study, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candace Tefertiller, PT, DPT, PhD, NCS
Organizational Affiliation
Craig Hospital, Colorado, United States
Official's Role
Principal Investigator
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Shepherd Center- Crawford Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
INSPIRE Laboratory, Spaulding Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29877852
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.
Results Reference
background
PubMed Identifier
24244094
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.
Results Reference
background
Learn more about this trial
LIFT Home Study of Non-Invasive ARC Therapy for Spinal Cord Injury
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