NCT03201094

Impact of NMES and HPRO on Recovery After SAH- Pilot Study

Impact of Neuromuscular Stimulation and High Protein Nutritional Supplementation on Long-term Recovery After Aneurysmal Subarachnoid Hemorrhage.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study purpose is to investigate the hypothesis that in adults with SAH, early neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) will improve muscle mass, metabolic and inflammatory biomarker profiles, compared to SAH controls receiving standard of care interventions for nutrition and mobilization. The investigators will accomplish this by studying the effects of a high protein (HPRO) nutritional treatment as well as NMES intervention have upon muscle wasting and motor strength acutely after SAH. This will be addressed in a prospective trial of SAH patients receiving HRPO with NMES as compared to age and severity-matched SAH patients undergoing standard of care interventions for nutrition and mobilization. Additionally, the study will investigate the impact HPRO and NMES interventions have upon inflammatory cytokines and markers of energy balance. Results of this study will establish evidence for precision nutrition plus early exercise to mitigate the catabolic and inflammatory state produced by SAH to improve muscle, metabolic, and health recovery outcomes.

Conditions

• Subarachnoid Hemorrhage
• Muscle Atrophy
• Inflammation
• Nutritional and Metabolic Disease

Interventions

Type	Name	Description
DEVICE	Neuromuscular Electrical Stimulation (NMES)	Neuromuscular electrical stimulation twice daily during study period.
DIETARY_SUPPLEMENT	High Protein Supplementation	High protein supplementation with whey protein shakes taken three times a day during study period.

Timeline

• Start date: 2017-12-01
• Primary completion: 2026-05-31
• Completion: 2026-10-30
• First posted: 2017-06-28
• Last updated: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study