Empower BP is a pivotal, interventional, multicenter, prospective, randomized, sham-controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (\>1 year after SCI). The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant. Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (active or sham) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Implantation of the ARC-IM Thoracic Lead in the epidural space and ARC-IM Neurostimulator
The ARC-IM System is programmed since day 0 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury
The ARC-IM System is programmed at month 3 to deliver active electrical spinal cord stimulation (after 3 months of sham stimulation) at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury
Craig Hospital
Englewood, Colorado, United States
RECRUITINGUofL Health - Frazier Rehabilitation Institute
Louisville, Kentucky, United States
RECRUITINGSpaulding Rehabilitation
Cambridge, Massachusetts, United States
RECRUITINGOregon Health & Science University
Portland, Oregon, United States
RECRUITINGProportion of subjects achieving a change in the hypotension domain of the ADFSCI short-form questionnaire
Proportion of subjects achieving a reduction of ≥ 4 points in the hypotension domain of the ADFSCI short-form questionnaire compared to baseline
Time frame: 3-months post-implant
Proportion of subjects achieving elevation in SBP during seated BP test
Proportion of subjects achieving an elevation of ≥ 10 mmHg in systolic blood pressure during the seated BP test with stimulation ON compared to stimulation OFF
Time frame: 3-months post-implant
Incidence of serious adverse device effects
Description of all Serious Adverse Device Effects from ARC-IM System implant until Month 6
Time frame: 6-months post-implant
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