NCT03201094 Impact of NMES and HPRO on Recovery After SAH- Pilot Study
| NCT ID | NCT03201094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Subarachnoid Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2017-12-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2017-12-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Neeraj Badjatia, MD MSc
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT03201094 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Subarachnoid Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03201094 currently recruiting?
Yes, NCT03201094 is actively recruiting participants. Contact the research team at nbadjatia@umm.edu for enrollment information.
Where is the NCT03201094 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03201094 clinical trial?
NCT03201094 is sponsored by University of Maryland, Baltimore. The principal investigator is Neeraj Badjatia, MD MSc at University of Maryland, Baltimore. The trial plans to enroll 30 participants.