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

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jun 27, 2017

Keywords

ClinConnect Summary

This clinical trial, called the "Impact of NMES and HPRO on Recovery After SAH- Pilot Study," is exploring how two specific treatments can help adults recover better after a subarachnoid hemorrhage (SAH), which is a type of bleeding in the brain. The study focuses on using neuromuscular electrical stimulation (NMES), a method that stimulates muscles with small electrical impulses, along with high protein supplementation (HPRO), which means providing extra protein in their diet. Researchers will compare patients getting these treatments to those receiving standard care to see if the combined approach can improve muscle strength and reduce inflammation, helping patients recover more effectively.

To qualify for this trial, participants need to be between 25 and 80 years old and have been diagnosed with aneurysmal SAH, with their aneurysm treated within 48 hours of the bleeding. They should expect to stay in the intensive care unit (ICU) for more than three days. This study aims to provide valuable insights into how tailored nutrition and early physical stimulation can support recovery after a serious health event like SAH. Participants will be closely monitored, and their progress will help shape future treatments for similar conditions.

Gender

ALL

Eligibility criteria

• 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.