Motor and autonomic concomitant health improvements with neuromodulation and exercise (MACHINE) training: a randomised controlled trial in individuals with spinal cord injury

BMJ Open, 2023 · DOI: 10.1136/bmjopen-2022-070544 · Published: January 1, 2023

Spinal Cord Injury Neurology Rehabilitation

Simple Explanation

This study aims to determine if combining locomotor training (LT) with transcutaneous spinal cord stimulation (TSCS) can improve sensorimotor and autonomic function in people with chronic, motor-complete spinal cord injury (SCI). Participants will be randomly assigned to either LT+TSCS or LT+Sham stimulation for 12 weeks, after which postintervention assessments will be performed to determine the effect of TSCS on motor and autonomic functions. The primary outcome is attempted voluntary muscle activation, while secondary outcomes relate to sensorimotor function, cardiovascular function, pelvic organ function, and health-related quality of life.

Study Duration

12 weeks intervention, 18 weeks participation

Participants

12 adults with chronic (>1 year) motor-complete SCI

Evidence Level

Level 1, Single-blinded, randomised sham-controlled trial

Key Findings

1
The primary outcome of interest is attempted voluntary muscle activation using surface electromyography.
2
The secondary outcomes relate to sensorimotor function, cardiovascular function, pelvic organ function and health-related quality of life.
3
The study will assess the effects of LT paired with TSCS in people with chronic SCI on outcomes of sensorimotor and autonomic function.

Research Summary

This study investigates the efficacy of combining locomotor training (LT) with transcutaneous spinal cord stimulation (TSCS) to promote recovery of sensorimotor and autonomic function in individuals with chronic, motor-complete spinal cord injury (SCI). The study is a single-blind, randomized, sham-controlled trial, with participants undergoing 12 weeks of either LT+TSCS or LT+Sham stimulation. The primary outcome is attempted voluntary muscle activation. Secondary outcomes include sensorimotor function, cardiovascular parameters, pelvic organ function, and health-related quality of life. The trial aims to provide insight into the efficacy of combined treatments for restoring functional activities and autonomic regulation in SCI.

Practical Implications

Therapeutic Potential

The paired approach of LT with TSCS offers a viable, novel and non-pharmacological treatment option for SCI recovery.

Personalized Treatment

The flexibility of the paired intervention allows the simultaneous targeting of both motor and autonomic dysfunctions, serving the priorities of individuals with SCI.

Precise Treatment Parameters

Insight into the efficacy of combined treatments will offer precise treatment parameters for restoration of functional activities and autonomic regulation in individuals with SCI.

Study Limitations

1
The lack of a follow-up time point for physiological outcomes to ascertain whether favorable adaptations persist beyond the intervention period.
2
Sample size is informed by previous studies with a similar sample size (n=12–13).
3
Not specified

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