LIFT Home Study of Non-Invasive ARC Therapy for Spinal Cord Injury

ONWARD Medical

Status: Completed

Conditions: Chronic Spinal Cord Injury

Treatments: Device: LIFT System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05284201

DOC2530

Pro00059716 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion 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, occupational therapist or physical therapist
5. Minimum 12 months post-injury
6. Capable of providing informed consent
7. Completed the Up-LIFT Study within the prior 12 months

Exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Functional task practice and ARC Therapy

Experimental group

Description:

FTP and ARC Therapy with the LIFT System at home for 1 month.

Treatment:

Device: LIFT System