Chronic Spinal Cord InjuryNCT05284201
LIFT Home 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 5 sites in United States.
Trial 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. 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
- 17 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Mar 2022to 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
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Shepherd Center- Crawford Research Institute
Atlanta, Georgia, 30303
INSPIRE Laboratory, Spaulding Hospital
Cambridge, Massachusetts, 02138
Craig Hospital
Englewood, Colorado, 80113
University of Minnesota
Minneapolis, Minnesota, 55441
University of Washington
Seattle, Washington, 98195
About this study
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.
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.
Read the 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
- 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 Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia.
| Study group | Role | What they receive |
|---|---|---|
| Functional task practice and ARC Therapy | Experimental | FTP and ARC Therapy with the LIFT System at home for 1 month. Receives: Device: LIFT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through completion of the study, an average of 6 months
Secondary outcomes (1)
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.
Measured: Through completion of the study, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start3 Mar 2022
- 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- ONWARD Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Candace Tefertiller, PT, DPT, PhD, NCS, Principal investigator, Craig Hospital, Colorado, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284201
- Sponsor's protocol ID
- DOC2530
- Other IDs
- Pro00059716
- Status last verified
- Sep 2022
- First submitted
- 9 Mar 2022
- 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 24244094Tefertiller 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.
PubMed 41019097
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
- Safety and Performance Assessment of the LIFT System When Used to Support Home-based Upper Extremity Training in Individuals With Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT05284201
- Acronym / sponsor ID
- DOC2530
- Conditions
- Chronic Spinal Cord Injury
- Keywords
- SCI, Tetraplegia, ARC therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- ONWARD Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 17 Mar 2022 (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 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.
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 and ARC Therapy | Experimental | Device: LIFT SystemFTP and ARC Therapy with the LIFT System at home for 1 month. |
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, occupational therapist or physical therapist
- Minimum 12 months post-injury
Key exclusion criteria (11 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 Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia. | Device | Functional task practice and ARC Therapy |
Primary outcome
Incidence of all adverse events (AEs)
Time frame: Through completion of the study, an average of 6 months
Observational data regarding the incidence of all adverse events related to the use of the study device and treatment procedures will be reported.
1 secondary outcome
Extended use of the LIFT System at home
Time frame: Through completion of the study, an average of 6 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 41019097Tefertiller 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.
- 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.
Candace Tefertiller, PT, DPT, PhD, NCS principal investigator
Craig Hospital, Colorado, United States
5 sites in 1 country: 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 5 sites in United States.
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 11 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 5 sites in United States. 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 all adverse events (AEs) (time frame: Through completion of the study, an average of 6 months). 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 NCT05284201, 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.