Recruiting

NMES & HPRO

Sponsor:

University of Maryland, Baltimore

Code:

NCT03201094

Conditions

Subarachnoid Hemorrhage

Muscle Atrophy

Inflammation

Nutritional and Metabolic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neuromuscular Electrical Stimulation (NMES)

High Protein Supplementation

Study Details

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.

Conditions

Subarachnoid Hemorrhage

Muscle Atrophy

Inflammation

Nutritional and Metabolic Disease

Study ID

NCT03201094

Start date

Dec 1, 2017

Status verified date

Sep, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Neuromuscular Electrical Stimulation (NMES)

Neuromuscular electrical stimulation twice daily during study period.

High Protein Supplementation

High protein supplementation with whey protein shakes taken three times a day during study period.

Primary outcome measure

  • Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period. [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Neeraj Badjatia, MD MSc

4103284515nbadjatia@umm.edu

Locations

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Neeraj Badjatia, MD MS

4103284515nbadjatia@umm.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-09-04.