Using electrical stimulation and high protein diet to aid recovery after brain hemorrhage

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

This study is testing if using electrical stimulation and a high protein diet can help adults recover better after a brain hemorrhage compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT03201094 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of early neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) on recovery in adults diagnosed with subarachnoid hemorrhage (SAH). Participants will be divided into two groups: one receiving NMES and HPRO, and the other receiving standard care. The study aims to assess improvements in muscle mass, metabolic and inflammatory biomarkers, and motor strength. By comparing these outcomes, the researchers hope to establish a more effective recovery protocol for SAH patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 25 to 80 who have been diagnosed with aneurysmal SAH and are expected to stay in the neurocritical care unit for more than 72 hours.

Not a fit: Patients with SAH from non-aneurysmal causes, severe pre-existing conditions, or those unlikely to survive the week post-hemorrhage may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance recovery outcomes for patients after subarachnoid hemorrhage.

How similar studies have performed: While the specific combination of NMES and HPRO in SAH patients is novel, similar interventions have shown promise in other populations for improving recovery outcomes.

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.

Where this trial is running

Baltimore, Maryland

• University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Neeraj Badjatia, MD MSc — University of Maryland, Baltimore
• Study coordinator: Neeraj Badjatia, MD MSc

Conditions Subarachnoid Hemorrhage; Muscle Atrophy; Inflammation; Nutritional and Metabolic Disease