Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury (BoxSwitch)

Technology

General health

Online since 21 November 2023, updated 535 days ago

About this trial

This trial is enrolling 8 individuals with chronic spinal cord injury to test the safety and effect of targeted epidural spinal stimulation on mobility. Targeted epidural spinal stimulation is a technique for stimulating the spinal cord with an implanted electrode array placed next to the spinal cord to modify spinal cord function. Only people with spinal cord injury who previously participated in the STIMO study (see NCT02936453) will be eligible to participate in this study. If included, participants will undergo surgery to replace parts of their current implanted system with components of the ARC-IM Lumbar system, followed by 20 optimization sessions. Then, participants will use the stimulation system independently during daily life activities for 36 months, at which point final testing of safety and mobility will be performed.

Included participants

Gender

All

Age

18 - 65 years

Injury level

C1 - T10

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

≥ 12 months

Injury type

Traumatic

Healthy volunteers

C1-T10

Additionally, participants must

have completed the main phase of the STIMO study (NCT02936453) and improved on at least one of the primary or secondary endpoints

What’s involved

Type

Technology

Details

- participants will undergo surgery to replace parts of their current implanted system with components of the ARC-IM Lumbar system - 20 optimization sessions that may include rehabilitation to configure the neuromodulation system - use of the ARC-IM system independently during daily life activities until the end of the 36 months post-surgery - final testing of safety and mobility will be performed after 36 months

Potential benefits

Main benefits

General health

Additional benefits

Arm/hand function

Mental health and psychosocial factors

Sensory function

Spasticity

Standing/walking/mobility

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

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