What this study is
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.
What's being tested
- Neuromuscular Electrical Stimulation (NMES)
Intervention · DEVICE
Neuromuscular electrical stimulation twice daily during study period.
- High Protein Supplementation
Intervention · DIETARY SUPPLEMENT
High protein supplementation with whey protein shakes taken three times a day during study period.
Study details
- Official title
- Impact of Neuromuscular Stimulation and High Protein Nutritional Supplementation on Long-term Recovery After Aneurysmal Subarachnoid Hemorrhage.
- Sponsor
- University of Maryland, Baltimore
- Conditions
- Subarachnoid Hemorrhage · Muscle Atrophy · Inflammation · Nutritional and Metabolic Disease
- Enrolling
- 30 people
- Starts
- 2017-12-01
- Est. completion
- 2026-10-30
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- . 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.
You can't join if
- . 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Maryland Medical Center
Baltimore, Maryland, United States
- Neeraj Badjatia, MD MS · Contact4103284515nbadjatia@umm.edu
Recruiting
Study team
Sponsor
University of Maryland, Baltimore
Study ID HP-00074174
Principal investigator
Neeraj Badjatia, MD MSc
University of Maryland, Baltimore
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.