Clinical trial NCT03201094: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subarachnoid Hemorrhage
Muscle Atrophy
Inflammation
Nutritional and Metabolic Disease
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Neeraj Badjatia, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: