Reduction of Muscle Catabolism Through Brain Activation in Burn Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Burn-Bundle Extended Rehabilitation Program: A multimodal brain-activating rehabilitation program consisting of inhalational isoflurane sedation combined with functional proprioceptive stimulation, repetitive transcranial magnetic stimulation, and virtual reality-assisted rehabilitation when consciousness allows, applied during the acute phase after severe burn injury.

Isoflurane Inhalational Sedation: Sedation with inhaled isoflurane administered via an anesthetic conserving device during invasive mechanical ventilation, used as an alternative to standard intravenous sedatives.

Functional Proprioceptive Stimulation: Illusory movements induced by focal vibration of muscle attachments to activate central motor pathways, applied twice daily during the acute phase of critical illness.

Neurorehabilitation Techniques: Non-invasive neurorehabilitation techniques including repetitive transcranial magnetic stimulation and virtual reality-assisted rehabilitation applied to enhance cortical activation and neuroplasticity in critically ill burn patients when clinically feasible.

Study summary

Patients with extensive burn injuries frequently develop severe skeletal muscle wasting and weakness as part of critical illness-related myopathy and neuropathy. This condition delays ventilator weaning, prolongs intensive care unit (ICU) and hospital stay, and contributes to long-term functional impairment and reduced quality of life. In burn patients, muscle loss is particularly pronounced during the early post-injury phase and is associated with mitochondrial dysfunction and altered neuromuscular signaling.

Effective strategies to prevent muscle catabolism in critically ill burn patients remain limited. Although early active rehabilitation is beneficial, many patients are unable to participate due to deep sedation, mechanical ventilation, or clinical instability. Therefore, innovative rehabilitation approaches applicable during the acute phase of critical illness are needed.

The REMBRANT (REduction of Muscle catabolism through BRAin activation in burn patieNTs) study is a single-center, randomized, controlled, open-label clinical trial evaluating whether a multimodal brain-activating rehabilitation strategy can attenuate skeletal muscle loss in adult patients with severe burns. Thirty patients with burns involving more than 30% of total body surface area who require invasive mechanical ventilation and prolonged sedation will be randomized in a 1:1 ratio to standard care or an intervention group.

Both groups will receive standardized burn treatment and conventional rehabilitation. The intervention group will additionally receive the Burn-Bundle Extended Rehabilitation Program, combining inhalational isoflurane sedation with functional proprioceptive stimulation, repetitive transcranial magnetic stimulation, and virtual reality-assisted rehabilitation when clinically feasible.

The primary outcome is change in skeletal muscle mass and strength. Secondary outcomes include ICU length of stay, ventilator-free days, mitochondrial function, and health-related quality of life.

Eligibility

Primary outcome measure(s)

• Change in skeletal muscle mass assessed by dual-energy X-ray absorptiometry (DEXA) — From baseline (within first 7 days after ICU admission) up to 24 weeks.
  Change in lean body mass measured by dual-energy X-ray absorptiometry. Lean mass is reported in kilograms (kg).
• Change in rectus femoris muscle thickness assessed by ultrasound — From baseline (day 10 after injury) to day 30 after injury
  Change in rectus femoris muscle thickness measured by ultrasound. Muscle thickness is reported in millimeters (mm).
• Change in muscle strength assessed by the Medical Research Council (MRC) Sum Score — From baseline (within first 7 days after ICU admission) up to 24 weeks.
  Muscle strength assessed using the Medical Research Council (MRC) Sum Score. The MRC Sum Score ranges from 0 to 60, with higher scores indicating greater muscle strength.

Trial sites (1)

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