Impact of Neuromuscular Stimulation and High Protein Nutritional Supplementation on Long-term Recovery After Aneurysmal Subarachnoid Hemorrhage.

Status: Recruiting
Location: See location...
Intervention Type: Device, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• . 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.

Locations
United States
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
Contact Information
Primary
Neeraj Badjatia, MD MSc
nbadjatia@umm.edu
4103284515
Time Frame
Start Date: 2017-12-01
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 30
Treatments
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.
Experimental: NMES only
Patients will undergo two 30 minute NMES sessions per day during study period.
Experimental: HPRO only
Patients will receive HPRO three times daily during study period
Related Therapeutic Areas
Sponsors
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov