Actively Recruiting
Impact of NMES and HPRO on Recovery After SAH- Pilot Study
Led by University of Maryland, Baltimore · Updated on 2024-10-15
30
Participants Needed
1
Research Sites
465 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of NMES and HPRO on Recovery After SAH- Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with aneurysmal subarachnoid hemorrhage (SAH)
- Underwent aneurysmal repair within 48 hours of bleeding event
- Age between 25 and 80 years old
- Expected to stay in the neurocritical care unit for more than 72 hours
- Admission Hunt Hess Grade 2 or higher
- Modified Fisher score greater than 1
You will not qualify if you...
- SAH caused by trauma, arteriovenous malformation rupture, tumor, vasculitis, or other secondary causes
- Expected to not survive one week after hemorrhage due to brain death or planned withdrawal of care
- Expected ICU stay less than 7 days
- Body mass index less than 15 or greater than 40 kg/m2
- Allergy to whey protein
- Lower extremity weakness or spasticity within 48 hours of injury
- Premorbid modified Rankin Score greater than 1
- Known pregnancy
- Active malignancy
- Diagnosis of inflammatory disorder
- Presence of neuromuscular disorder
- Chronic kidney failure or acute kidney injury with low kidney function
- Liver failure with elevated liver enzymes more than 2.5 times above normal
- Ongoing seizure activity detected clinically or by EEG at enrollment
- Prisoner
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
N
Neeraj Badjatia, MD MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here