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The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury (Up-LIFT)

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ClinicalTrials.gov Identifier: NCT04697472
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
ONWARD Medical, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Spinal Cord Injury Device: LIFT System Not Applicable

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 -

  1. Safety,
  2. Relevance to UE function,
  3. Capture improvements in performance, and
  4. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional task practice (FTP) followed by FTP + ARC Therapy
Clinic-based functional task practice (FTP) for two months followed by FTP + ARC Therapy for an additional 2 months.
Device: LIFT System
The LIFT System delivers the ARC Therapy to improve upper extremity function in individuals with tetraplegia.




Primary Outcome Measures :
  1. 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.

  2. 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).



Secondary Outcome Measures :
  1. Superiority of combined FTP and ARC Therapy with LIFT vs. FTP alone. [ Time Frame: Through completion of the study, an average of 16 months ]
    Superiority as demonstrated by statistically significant difference in the proportion of subjects reporting improvement between the two treatment groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

Subjects must meet all the following criteria:

  1. At least 22 years old and no older than 75 years old at the time of enrollment
  2. Non-progressive cervical spinal cord injury from C2-C8 inclusive
  3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D
  4. Indicated for upper extremity training procedures by subject's treating physician or a physical therapist
  5. Minimum 12 months post-injury
  6. Capable of providing informed consent

Key Exclusion Criteria:

Subjects must not meet any of the following criteria:

  1. Has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the Investigator
  2. 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
  3. Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled
  4. Requires ventilator support
  5. Has an autoimmune etiology of spinal cord dysfunction/injury
  6. Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
  7. Breakdown in skin area that will come into contact with electrodes
  8. Has any active implanted medical device
  9. Pregnant, planning to become pregnant or currently breastfeeding
  10. Concurrent participation in another drug or device trial that may interfere with this study
  11. In the opinion of the investigators, the study is not safe or appropriate for the participant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697472


Contacts
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Contact: www.ONWD.com +31 (0)40 288 2830 uplift@onwd.com

Locations
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United States, Georgia
Shepherd Center- Crawford Research Institute Recruiting
Atlanta, Georgia, United States, 30303
Contact: Edelle Field-Fote, PT, PhD         
Contact: Allison McIntyre, MOT, OT/L         
United States, Massachusetts
INSPIRE Laboratory, Spaulding Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Randy D Trumbower, PT, PhD         
Contact: Stella Barth, BA         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Chet Moritz, PT, PhD         
Sponsors and Collaborators
ONWARD Medical, Inc.
Investigators
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Principal Investigator: Edelle Field-Fote, PT, PhD Shepherd Center - Crawford Research Institute
Principal Investigator: Chet Moritz, PT, PhD University of Washington
Publications:
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Responsible Party: ONWARD Medical, Inc.
ClinicalTrials.gov Identifier: NCT04697472    
Other Study ID Numbers: DOC1622
Pro00046320 ( Other Identifier: Advarra )
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by ONWARD Medical, Inc.:
SCI
Tetraplegia
ARC Therapy
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System