Safety: To provide confirmatory evidence that use of the LIFT System, inclusive of all components and accessories, is safe.Effectiveness: To provide confirmatory evidence that use of the LIFT System provides an effective treatment for the…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Observational data regarding the incidence of serious adverse events
(SAEs) related to the use of the study device and treatment procedures will be
reported.
Effectiveness: The primary effectiveness outcome measure will test the
hypothesis that a majority of the subjects will experience clinically
significant improvement in selected strength and functional performance metrics
after treatment with ARC Therapy administered by the LIFT System and FTP. A
subject will be considered a treatment responder if she/he reports clinically
relevant improvements in at least one outcome each in the Strength and Function
domains as follows:
Strength: ISNCSCI-UEMS, GRASSP-Strength, CUE-T, Pinch force, Grasp
force
Function: GRASSP-Prehension, CUE-T
Secondary outcome
Safety: All adverse events (AEs) and SAEs in the study will be reported.
Effectiveness: To capture meaningful improvements in established outcomes
assessing upper extremity function, the following hierarchical testing will be
carried out. These endpoints will be tested in descending order of importance
through hierarchical testing as described in the Statistical Analysis Plan
(SAP).
- Superiority of combined MPT and ARC Therapy with LIFT vs. FTP alone as
described by statistically significant difference in responder rates
(comparison of change from enrollment baseline to end of FTP with the change
from enrollment baseline to end of combined FTP and ARC Therapy with LIFT)
- Quantitative comparison of individual performance metrics to establish
superiority of FTP and ARC Therapy with LIFT compared to FTP alone:
- Pinch force
- GRASSP-Prehension
- GRASSP-Strength
- ISNCSCI-UEMS
- ISNCSCI-Total sensory score
- EQ-5D-5L
- SCIM
- WHOQOL-BREF
Background summary
Non-invasive Electrical Spinal Cord Stimulation may be used in conjunction with
conventional rehabilitation therapy in patients with Spinal Cord Injury (SCI)
to improve the recovery of physiological function following injury. The LIFT
System from ONWARD Medical, Inc. is designed to help people experiencing
paralysis due to injury, to help regain mobility, independence, and an improved
quality of life. The LIFT System is a transcutaneous spinal cord stimulator
that is externally connected to the patient using body surface electrodes.
Stimulation pulses are provided to the patient to reactivate damaged and
dormant neural circuits through neuromodulation of the spinal cord. The
patients are able to re-learn patterns of activation associated with pre-injury
function. The LIFT System is designed to be used in the hospital and at a
rehabilitation therapy clinic.
The scientific basis for development of the LIFT System is predicated upon
research studies performed on animal and human subjects with SCI that
demonstrated that residual (spared) sensory and motor pathways were critical in
mediating the voluntary movements that are possible when ARC Therapy delivered
by the LIFT system is paired with task-based training by the individual. These
studies demonstrated that either hand or lower extremity training combined with
repetitive spinal cord stimulation drove neural plasticity that eventually
resulted in the ability to improve voluntarily hand function and standing,
respectively. Application of ARC Therapy combined with rehabilitation therapy
could be used not just to restore physical movement of upper and lower
extremities but also for improvement of autonomic functions and stroke
rehabilitation to SCI patients afflicted with paralysis.
Study objective
Safety: To provide confirmatory evidence that use of the LIFT System, inclusive
of all components and accessories, is safe.
Effectiveness: To provide confirmatory evidence that use of the LIFT System
provides an effective treatment for the restoration or improvement
in UE strength and function.
Other: To provide data regarding the potential benefits of the LIFT System to
achieve other secondary outcomes such as improvement in pain,
spasticity, quality of life, cardiovascular (blood pressure) and autonomic
function.
Study design
The Up-LIFT Study is a prospective, single-arm study designed to evaluate the
safety and effectiveness of non-invasive electrical spinal stimulation
(ARC Therapy) administered by the LIFT System to treat upper extremity
functional deficits in people with chronic tetraplegia. The primary endpoint
of this pivotal study will report device related safety and changes in
established metrics of upper extremity function and strength after treatment
with the study device.
To ensure that the benefits realized in the study are directly attributable to
the ARC Therapy administered by the LIFT System, all enrolled subjects
will first undergo a guided, in-clinic conventional functional task practice
(FTP) program lasting approximately two months to regain strength and
function of their upper extremities (UE). Performance gains realized during the
wash-in period provide a subject specific control that reflects the limits of
conventional FTP without stimulation (standard of care). At the conclusion of
the wash-in period, subjects will complete pre-stimulation
baseline testing of UE function.
To test the additive benefit of training with stimulation, combined FTP and ARC
Therapy will then be administered over a period of approximately two months
using the LIFT System. FTP will follow established rehabilitation protocols
that are specific to the individual subject*s specific needs and capabilities
(Gomes-Osman, Tibbett, Poe, & Field-Fote, 2017). Training will be graded to
accommodate performance improvement over time, thus maximizing the potential
benefit to subjects. To ensure consistency and safety, subjects will
participate in a minimum of 12 and a maximum of 20 in-clinic training sessions
per month. At the conclusion of this primary training period, changes in UE
strength and function will be measured
without active stimulation therapy and used to assess the 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 both strength and function, 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.
Study burden and risks
Living with SCI has historically meant learning to cope with disability and
worsening symptoms over time. In contrast, it has been shown through research
studies that using neuromodulatory techniques to alter physiological state of
spinal networks yields significant levels of retained clinically relevant
function in subjects with varying levels of paralysis as a result of spinal
cord injury. This has been proven using both transcutaneous and epidural spinal
cord stimulation systems on human subjects. Patient benefits have included
recovery or improvement in voluntary movement of the lower and upper
extremities, trunk control, cardiovascular function, thermoregulation,
independent standing, activities of daily living, and quality of life. In some
cases, these benefits have resulted in a decrease of healthcare costs for the
patients.
Potential Benefits to Study Subjects
Receiving benefit from participation in the study is not guaranteed.
Anticipated benefits to subjects may include, but are not limited to, the
following:
- Improved hand and/or arm muscle strength and prehension (ability to pinch,
grasp)
- Improved light touch and/or pinprick sensation in the dermatomes at, below or
above the level of lesion
- Improved quality of life
- Improved bladder, bowel, or sexual function
- Reduced frequency of spasticity (if present at baseline)
Potential Risks to Study Subjects
Risks to study subjects enrolled in this study include all those risks commonly
associated with all TENS and NMES devices including skin rash at the site of
application of the surface electrode, electric shock from the stimulator unit,
unpleasant tingling or buzzing sensation at skin surface and cramping of the
muscles. Other risks are identified in Sections 13.4 and 13.5.
7 Carmel Circle 7
Lexington, MA 02421
US
7 Carmel Circle 7
Lexington, MA 02421
US
Listed location countries
Age
Inclusion 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
Exclusion criteria
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. Presence of syringomyelia as confirmed by an MRI
12.Total baclofen dose >30 mg per day
13. In the opinion of the investigators, the study is not safe or appropriate
for the participant
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04697472 |
| CCMO | NL76734.091.21 |