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

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: Subarachnoid Hemorrhage; Muscle Atrophy; Inflammation; Nutritional and Metabolic Disease

Treatments: Dietary Supplement: High Protein Supplementation; Device: Neuromuscular Electrical Stimulation (NMES)

Study type: Interventional

Funder types: Other

Identifiers

NCT03201094

HP-00074174

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 4 patient groups

Standard of Care

No Intervention group

Description:

Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.

HPRO + NMES

Experimental group

Description:

Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.

Treatment:

Device: Neuromuscular Electrical Stimulation (NMES)

Dietary Supplement: High Protein Supplementation

NMES only

Experimental group

Description:

Patients will undergo two 30 minute NMES sessions per day during study period.

Treatment:

Device: Neuromuscular Electrical Stimulation (NMES)

HPRO only

Experimental group

Description:

Patients will receive HPRO three times daily during study period

Treatment:

Dietary Supplement: High Protein Supplementation