Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

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 details
    Subarachnoid Hemorrhage
    Muscle Atrophy
    Inflammation
    Nutritional and Metabolic Disease

NCT03201094

University of Maryland, Baltimore

8 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.