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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. . Being diagnosed with aneurysmal SAH 2. . Aneurysmal repair within 48 hours of ictus. 3. . Age between 25 and 80 years old. (>=25 years old and <=80 years old) 4. . Expected stay in the NCCU > 72 hours. 5. . Admission Hunt Hess Grade >=2. 6. modified Fisher score >1.

Exclusion Criteria

  1. . Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes; 2. . Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care; 3. . Unlikely to remain in the ICU for more than 7 days; 4. . Body mass index < 15 or >40 kg/m2; 5. . Allergy to whey protein; 6. . Evidence of lower extremity paresis or spasticity within 48 hours of injury 7. . Pre-morbid modified Rankin Score >1. 8. . Known pregnancy 9. . Presence of active malignancy 10. . Diagnosis of an inflammatory disorder 11. . Presence of a neuromuscular disorder 12. . Diagnosis of chronic renal insufficiency or acute kidney injury (GFR < 30 mL/min/1.73m2) 13. . Hepatic insufficiency defined as AST/ALT levels >2.5 above normal upper limits. 14. . On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment 15. . Prisoner.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard of Care 		Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.
Experimental
HPRO + NMES 		Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.
  • 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.
Experimental
NMES only 		Patients will undergo two 30 minute NMES sessions per day during study period.
  • Device: Neuromuscular Electrical Stimulation (NMES)
    Neuromuscular electrical stimulation twice daily during study period.
Experimental
HPRO only 		Patients will receive HPRO three times daily during study period
  • Dietary Supplement: High Protein Supplementation
    High protein supplementation with whey protein shakes taken three times a day during study period.

Recruiting Locations

University of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Neeraj Badjatia, MD MS
4103284515
nbadjatia@umm.edu

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Neeraj Badjatia, MD MSc
4103284515
nbadjatia@umm.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.