ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

Technology

General health

Online since 5 June 2024, updated 315 days ago

About this trial

This trial is enrolling 16 individuals with sub-acute to chronic spinal cord injury (at least one month post injury) to test the safety and effect of a spinal cord stimulation intervention called ARC-IM on blood pressure management and trunk control. ARC-IM is a technique for stimulating the spinal cord with implanted electrodes placed next to the spinal cord in the epidural space. If included, participants will receive surgery to implant the electrodes; electrical stimulation will be applied to the spinal cord. Final testing of safety measures will be performed after 12 months.

Included participants

Gender

All

Age

≥ 18 years

Injury level

C3 - T6

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

≥ 1 month

Injury type

Traumatic

Healthy volunteers

C3-T6

Additionally, participants must

have orthostatic hypotension.

must NOT have an indwelling baclofen or insulin pump

What’s involved

Type

Technology

Details

- participants will receive surgery for implantation of the ARC-IM System - stimulation will be applied to the spinal cord - final testing of safety measures will be performed after 12 months

Potential benefits

Main benefits

General health

Additional benefits

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

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