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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Muscle Atrophy; Subarachnoid Hemorrhage; Nutritional and Metabolic Disease
• Intervention / Treatment: Device: Neuromuscular Electrical Stimulation (NMES); Dietary supplement: High Protein Supplementation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neeraj Badjatia, MD MSc; Phone Number: 4103284515; Email: nbadjatia@umm.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center
      • Contact: Neeraj Badjatia, MD MS; Phone Number: 410-328-4515; Email: nbadjatia@umm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.
Experimental: HPRO + NMES; Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.	Device: Neuromuscular Electrical Stimulation (NMES); Neuromuscular electrical stimulation twice daily during study period.; Dietary supplement: High Protein Supplementation; High protein supplementation with whey protein shakes taken three times a day during study period.
Experimental: NMES only; Patients will undergo two 30 minute NMES sessions per day during study period.	Device: Neuromuscular Electrical Stimulation (NMES); Neuromuscular electrical stimulation twice daily during study period.
Experimental: HPRO only; Patients will receive HPRO three times daily during study period	Dietary supplement: High Protein Supplementation; High protein supplementation with whey protein shakes taken three times a day during study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period.	Change in the muscle layer thickness of the quadriceps muscle as measured by ultrasound.	14 days

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Neeraj Badjatia, MD MSc, University of Maryland School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): October 30, 2024

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Intracranial Hemorrhages; Inflammation; Hemorrhage; Muscular Atrophy; Subarachnoid Hemorrhage; Metabolic Diseases
• Other Study ID Numbers: HP-00074174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes