ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury

Conditions

• Blood Pressure Disorders
• Spinal Cord Injuries

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• ARC-IM System Implantation — PROCEDURE
  Implantation of the ARC-IM Thoracic Lead in the epidural space and ARC-IM Neurostimulator
• ARC-IM Therapy (Group 1) — DEVICE
  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
• ARC-IM Therapy (Group 2) — DEVICE
  The ARC-IM System is programmed at month 3 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

Study Details

Empower BP is a pivotal, interventional, multicenter, prospective, randomized, 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 (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) 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.

Key Dates

Start date

Oct 17, 2025

Status verified

May 2026

Primary completion

Nov 30, 2026

Completion

Mar 31, 2029

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Group 1
  ARC-IM System with active stimulation since day 0
• Sham Comparator: Group 2
  ARC-IM System without active stimulation before the open-label phase of the study

Primary Outcome Measure

Proportion of subjects achieving a change in the hypotension domain of the ADFSCI short-form questionnaire [ Time Frame: 3-months post-implant ]

Locations (12)

Find similar trials in Little Rock, AR

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