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NCT Number: NCT03201094

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • . 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.

Exclusion criteria

  • . Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;
  • . Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;
  • . Unlikely to remain in the ICU for more than 7 days;
  • . Body mass index < 15 or >40 kg/m2;
  • . Allergy to whey protein;
  • . Evidence of lower extremity paresis or spasticity within 48 hours of injury
  • . Pre-morbid modified Rankin Score >1.
  • . Known pregnancy
  • . Presence of active malignancy
  • . Diagnosis of an inflammatory disorder
  • . Presence of a neuromuscular disorder
  • . Diagnosis of chronic renal insufficiency or acute kidney injury (GFR < 30 mL/min/1.73m2)
  • . Hepatic insufficiency defined as AST/ALT levels >2.5 above normal upper limits.
  • . On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment
  • . Prisoner.

Treatment and study plan

Neuromuscular Electrical Stimulation (NMES)

Device

Neuromuscular electrical stimulation twice daily during study period.

High protein supplementation

Dietary Supplement

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

Primary outcomes

  1. 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

    Change in the muscle layer thickness of the quadriceps muscle as measured by ultrasound.

Study contacts

Contact information is provided by the study sponsor or research team.

Neeraj Badjatia, MD MSc

CONTACT

[email protected]

4103284515

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2017
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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