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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period. [Time frame: 14 days]

Eligibility criteria

Inclusion criteria

• . Being diagnosed with aneurysmal SAH
• . Aneurysmal repair within 48 hours of ictus.
• . Age between 25 and 80 years old. (>=25 years old and <=80 years old)
• . Expected stay in the NCCU > 72 hours.
• . Admission Hunt Hess Grade >=2.
• modified Fisher score >1.

Exclusion criteria

• . Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;
• . Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;
• . Unlikely to remain in the ICU for more than 7 days;
• . Body mass index < 15 or >40 kg/m2;
• . Allergy to whey protein;
• . Evidence of lower extremity paresis or spasticity within 48 hours of injury
• . Pre-morbid modified Rankin Score >1.
• . Known pregnancy
• . Presence of active malignancy
• . Diagnosis of an inflammatory disorder
• . Presence of a neuromuscular disorder
• . Diagnosis of chronic renal insufficiency or acute kidney injury (GFR < 30 mL/min/1.73m2)
• . Hepatic insufficiency defined as AST/ALT levels >2.5 above normal upper limits.
• . On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment
• . Prisoner.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Maryland Medical Center — Baltimore

Identifiers

NCT: NCT03201094 · HP-00074174

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗