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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00059716 | Other Identifier | Advarra |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional task practice and ARC Therapy | Experimental | FTP and ARC Therapy with the LIFT System at home for 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIFT System | Device | The LIFT System delivers the Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through completion of the study, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through completion of the study, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Candace Tefertiller, PT, DPT, PhD, NCS | Craig Hospital, Colorado, United States | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craig Hospital | Englewood | Colorado | 80113 | United States | ||
| Shepherd Center- Crawford Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29877852 | Background | 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. | |
| 24244094 | Background |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Atlanta |
| Georgia |
| 30303 |
| United States |
| INSPIRE Laboratory, Spaulding Hospital | Cambridge | Massachusetts | 02138 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55441 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| 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. |
| 41019097 | Derived | Tefertiller 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |