Effect of epidural spinal cord stimulation after chronic spinal cord injury on volitional movement and cardiovascular function: study protocol for the phase II open label controlled E-STAND trial

BMJ Open, 2022 · DOI: 10.1136/bmjopen-2021-059126 · Published: January 1, 2022

Spinal Cord Injury Neurology Rehabilitation

Simple Explanation

Spinal cord injury (SCI) leads to significant changes in morbidity, mortality and quality of life (QOL). Currently, there are no effective therapies to restore function after chronic SCI. Preliminary studies have indicated that epidural spinal cord stimulation (eSCS) is a promising therapy to improve motor control and autonomic function for patients with chronic SCI. The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function.

Study Duration

15 months

Participants

Participants with thoracic motor complete paraplegia

Evidence Level

Level II, Phase II single-site self-controlled trial

Key Findings

1
The central hypothesis of this study is that eSCS will restore some function in patients with chronic SCI that can be optimised using remotely collected data.
2
This is the first study to use a validated quantifiable outcome to objectively measure volitional movement and autonomic function during epidural stimulation in participants with motor complete spinal cord injury.
3
The high-volume data collected in this study will be used to assess for optimal stimulation programming parameters.

Research Summary

This study is a phase II single-arm preclinical–postclinical trial that measures outcomes at every assessment with intervention toggled on or off. All participants are assigned to a single treatment group. Participants will be enrolled in this study for a total of 15 months, including a screening and enrolment period of 3 months. Dysautonomia screening occurs at this time. At follow-up visits, the primary outcome measure assessment (magnitude of VRI mBMCA) is performed twice, once with the stimulator on and once without.

Practical Implications

Improved Motor Function

Epidural spinal cord stimulation (eSCS) may restore some volitional movement in patients with chronic SCI.

Cardiovascular Benefits

eSCS has the potential to improve cardiovascular function in individuals with spinal cord injury.

Optimized Stimulation Parameters

The study aims to optimize spinal cord stimulation parameters using remote data collection, potentially improving treatment efficacy.

Study Limitations

1
Because the inclusion criteria are broadened, more aggressive outcome measures such as standing training are not assessed due to potentially increased risk.
2
As this study involves no preparatory rehabilitation, the effect size of the function demonstrated with stimulation may be smaller than other studies.
3
The study is conducted at a single site, potentially limiting the generalizability of the findings.

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