Chronic Spinal Cord InjuryUp-LIFTNCT04697472
The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury
A study testing LIFT System in people with Chronic Spinal Cord Injury, run by ONWARD Medical, Inc. at 14 sites in 4 countries.
Trial summary
The Up-LIFT Study is a prospective, single-arm study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity functional deficits in people with chronic tetraplegia. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Chronic Spinal Cord Injury
- What is being tested?
- LIFT System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 8 Jan 2021to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all the following 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 or a physical therapist
- Minimum 12 months post-injury
- Capable of providing informed consent
Who cannot join
- Subjects must not meet any of the following 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
Show all 12Show fewer
- 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
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States9 sites
Shepherd Center- Crawford Research Institute
Atlanta, Georgia, 30303
INSPIRE Laboratory, Spaulding Hospital
Cambridge, Massachusetts, 02138
Craig Hospital
Englewood, Colorado, 80113
Miller School of Medicine, The Miami Project to Cure Paralysis
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55441
Thomas Jefferson University/Magee Rehabilitation Hospitals
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98195
James J. Peters VA Medical Center
The Bronx, New York, 10468
Canada2 sites
KITE Research Institute /University Health Network
Toronto, Ontario, M4G 3V9
International Collaboration on Repair Discoveries (ICORD), University of British Columbia
Vancouver, British Columbia, V5Z 1M9
Netherlands2 sites
Reade, Centre for Rehabilitation and Rheumatology
Amsterdam, North Holland, 1054 HW
Sint Maartenskliniek, Department of Rehabilitation
Nijmegen, Gelderland, 6574
United Kingdom1 site
Queen Elizabeth National Spinal Injuries Unit
Glasgow, G51 4TF
About this study
Official title: Clinical Assessment of Upper Extremity Performance in Individuals With Spinal Cord Injury Using the LIFT System to Deliver Non-invasive Electrical Spinal Stimulation (ARC Therapy)
The Up-LIFT Study is a prospective, single-arm study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity functional deficits in people with chronic tetraplegia.
Read the detailed description
The primary endpoint of this pivotal study will report device related safety and changes in established metrics of upper extremity performance after treatment with the study device.
To ensure that the benefits realized in the study are directly attributable to the ARC Therapy, all enrolled subjects will first undergo a guided, in-clinic conventional functional task practice (FTP) program lasting approximately two months to regain their upper extremity (UE) function. Performance gains realized during this wash-in period provide a subject specific control that reflects the limits of conventional functional task practice without stimulation (standard of care). At the conclusion of the wash-in period, subjects will complete pre-stimulation testing of UE function.
To test the additive benefit of training with stimulation, combined functional task practice and ARC Therapy will then be administered over a period of approximately two months using the LIFT System. Functional task practice will follow established rehabilitation protocols that are specific to the individual subject's specific needs and capabilities (Beekhuizen \& Field-Fote, Functional Task Practice versus Functional Task Practice with Stimulation: Effects on Upper Extremity Function and Cortical Plasticity in Individuals with Incomplete Cervical Spinal Cord Injury, 2005). Training will be graded to accommodate performance improvement over time, thus maximizing the potential benefit to subjects. Subjects will participate in up to 20 in-clinic training sessions per month. At the end of training period, the improvement in UE function will be measured and used to assess the progress of primary study endpoints.
The choice of primary outcome measures for this pivotal study is dictated by the following factors -
- Safety,
- Relevance to UE function,
- Capture improvements in performance, and
- Magnitude of changes that are clinically meaningful.
All performance metrics will be assessed at enrollment, at the completion of the wash-in period and at the end of the ARC Therapy assessment period. Subjects with clinically meaningful gains in multiple performance domains resulting from the ARC Therapy with LIFT will be considered responders. Additionally, gains during the wash-in (control) period will be compared to gains during the ARC Therapy with LIFT (test) period. Safety will be evaluated throughout the entire study through periodic monitoring and analysis of all reported adverse events.
- Conditions
- Chronic Spinal Cord Injury
- Being tested
- LIFT System
- Keywords
- SCI, Tetraplegia, ARC Therapy
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFT SystemDevice
The LIFT System delivers the ARC Therapy to improve upper extremity function in individuals with tetraplegia.
| Study group | Role | What they receive |
|---|---|---|
| Functional task practice (FTP) followed by FTP + ARC Therapy | Experimental | Clinic-based functional task practice (FTP) for two months followed by FTP + ARC Therapy for an additional 2 months. Receives: Device: LIFT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events (SAEs)
Safety demonstrated through observational data regarding the incidence of serious adverse events (SAEs) related to the use of the study device and treatment procedures will be reported.
Measured: Through completion of the study, an average of 16 months
Number of participants with change in upper extremity strength and function
Change in upper extremity strength and function performance metrics after treatment with ARC Therapy administered by the LIFT System and Functional Task Practice (FTP) is assessed using ISNCSCI, GRASSP,CUE-T, pinch/grasp forces.
The primary effectiveness outcome measure will test the hypothesis that a majority of the subjects will experience clinically significant improvement in UE performance metrics (defined as therapy responders) after treatment with ARC Therapy administered by the LIFT System and Functional Task Practice (FTP).
Measured: Through completion of the study, an average of 16 months
Secondary outcomes (1)
Superiority of combined FTP and ARC Therapy with LIFT vs. FTP alone.
Superiority as demonstrated by statistically significant difference in the proportion of subjects reporting improvement between the two treatment groups.
Measured: Through completion of the study, an average of 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start8 Jan 2021
- Primary completion30 Jun 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- ONWARD Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edelle Field-Fote, PT, PhD, Principal investigator, Shepherd Center - Crawford Research InstituteChet Moritz, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697472
- Sponsor's protocol ID
- DOC1622
- Other IDs
- Pro00046320
- Acronym
- Up-LIFT
- Status last verified
- Sep 2022
- First submitted
- 4 Dec 2020
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 29877852Hoffman 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.
PubMed 24244094Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20.
PubMed 38769431
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Upper Extremity Performance in Individuals With Spinal Cord Injury Using the LIFT System to Deliver Non-invasive Electrical Spinal Stimulation (ARC Therapy)
- ClinicalTrials.gov ID
- NCT04697472
- Acronym / sponsor ID
- Up-LIFT / DOC1622
- Conditions
- Chronic Spinal Cord Injury
- Keywords
- SCI, Tetraplegia, ARC Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- ONWARD Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Up-LIFT Study is a prospective, single-arm study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity functional deficits in people with chronic tetraplegia.
Detailed description
The primary endpoint of this pivotal study will report device related safety and changes in established metrics of upper extremity performance after treatment with the study device.
To ensure that the benefits realized in the study are directly attributable to the ARC Therapy, all enrolled subjects will first undergo a guided, in-clinic conventional functional task practice (FTP) program lasting approximately two months to regain their upper extremity (UE) function. Performance gains realized during this wash-in period provide a subject specific control that reflects the limits of conventional functional task practice without stimulation (standard of care). At the conclusion of the wash-in period, subjects will complete pre-stimulation testing of UE function.
To test the additive benefit of training with stimulation, combined functional task practice and ARC Therapy will then be administered over a period of approximately two months using the LIFT System. Functional task practice will follow established rehabilitation protocols that are specific to the individual subject's specific needs and capabilities (Beekhuizen \& Field-Fote, Functional Task Practice versus Functional Task Practice with Stimulation: Effects on Upper Extremity Function and Cortical Plasticity in Individuals with Incomplete Cervical Spinal Cord Injury, 2005). Training will be graded to accommodate performance improvement over time, thus maximizing the potential benefit to subjects. Subjects will participate in up to 20 in-clinic training sessions per month. At the end of training period, the improvement in UE function will be measured and used to assess the progress of primary study endpoints.
The choice of primary outcome measures for this pivotal study is dictated by the following factors -
- Safety,
- Relevance to UE function,
- Capture improvements in performance, and
- Magnitude of changes that are clinically meaningful.
All performance metrics will be assessed at enrollment, at the completion of the wash-in period and at the end of the ARC Therapy assessment period. Subjects with clinically meaningful gains in multiple performance domains resulting from the ARC Therapy with LIFT will be considered responders. Additionally, gains during the wash-in (control) period will be compared to gains during the ARC Therapy with LIFT (test) period. Safety will be evaluated throughout the entire study through periodic monitoring and analysis of all reported adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional task practice (FTP) followed by FTP + ARC Therapy | Experimental | Device: LIFT SystemClinic-based functional task practice (FTP) for two months followed by FTP + ARC Therapy for an additional 2 months. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 or a physical therapist
- Minimum 12 months post-injury
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIFT SystemThe LIFT System delivers the ARC Therapy to improve upper extremity function in individuals with tetraplegia. | Device | Functional task practice (FTP) followed by FTP + ARC Therapy |
Primary outcome
Incidence of serious adverse events (SAEs)
Time frame: Through completion of the study, an average of 16 months
Safety demonstrated through observational data regarding the incidence of serious adverse events (SAEs) related to the use of the study device and treatment procedures will be reported.
Number of participants with change in upper extremity strength and function
Time frame: Through completion of the study, an average of 16 months
Change in upper extremity strength and function performance metrics after treatment with ARC Therapy administered by the LIFT System and Functional Task Practice (FTP) is assessed using ISNCSCI, GRASSP,CUE-T, pinch/grasp forces. The primary effectiveness outcome measure will test the hypothesis that a majority of the subjects will experience clinically significant improvement in UE performance metrics (defined as therapy responders) after treatment with ARC Therapy administered by the LIFT System and Functional Task Practice (FTP).
1 secondary outcome
Superiority of combined FTP and ARC Therapy with LIFT vs. FTP alone.
Time frame: Through completion of the study, an average of 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 29877852Inanici 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.
- Background: PubMed 24244094Hoffman 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.
- Derived from this study: PubMed 38769431Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edelle Field-Fote, PT, PhD principal investigator
Shepherd Center - Crawford Research Institute
Chet Moritz, PhD principal investigator
University of Washington
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFT System in people with Chronic Spinal Cord Injury, run by ONWARD Medical, Inc. at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (SAEs) (time frame: Through completion of the study, an average of 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04697472, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.