RECRUITING

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

Conditions

Subarachnoid Hemorrhage Muscle Atrophy Inflammation Nutritional and Metabolic Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-12-01

Study Completion:2026-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03201094

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Neeraj Badjatia, MD MSc

CONTACT

4103284515

nbadjatia@umm.edu

Principal Investigator

Neeraj Badjatia, MD MSc

PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Study Locations (Sites)

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Neeraj Badjatia, MD MSc, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-12-01

Study Completion Date2026-10-30

Study Record Updates

Study Start Date2017-12-01

Study Completion Date2026-10-30

Terms related to this study

Additional Relevant MeSH Terms

Subarachnoid Hemorrhage
Muscle Atrophy
Inflammation
Nutritional and Metabolic Disease