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

NCT03201094 | Recruiting DMC FDA Device

• 1 other identifier: HP-00074174
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Standard of Care

NO INTERVENTION

Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.

HPRO + NMES

EXPERIMENTAL

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); Dietary Supplement: High Protein Supplementation

NMES only

EXPERIMENTAL

Patients will undergo two 30 minute NMES sessions per day during study period.

Device: Neuromuscular Electrical Stimulation (NMES)

HPRO only

EXPERIMENTAL

Patients will receive HPRO three times daily during study period

Dietary Supplement: High Protein Supplementation

Interventions

Neuromuscular Electrical Stimulation (NMES) DEVICE

Neuromuscular electrical stimulation twice daily during study period.

HPRO + NMES; NMES only

High Protein Supplementation DIETARY_SUPPLEMENT

High protein supplementation with whey protein shakes taken three times a day during study period.

HPRO + NMES; HPRO only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with aneurysmal SAH
• Aneurysmal repair within 48 hours of ictus.
• Age between 25 and 80 years old. (\>=25 years old and \<=80 years old)
• Expected stay in the NCCU \> 72 hours.
• Admission Hunt Hess Grade \>=2.
• modified Fisher score \>1.

You may not qualify if:

• Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;
• Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;
• Unlikely to remain in the ICU for more than 7 days;
• Body mass index \< 15 or \>40 kg/m2;
• Allergy to whey protein;
• Evidence of lower extremity paresis or spasticity within 48 hours of injury
• Pre-morbid modified Rankin Score \>1.
• Known pregnancy
• Presence of active malignancy
• Diagnosis of an inflammatory disorder
• Presence of a neuromuscular disorder
• Diagnosis of chronic renal insufficiency or acute kidney injury (GFR \< 30 mL/min/1.73m2)
• Hepatic insufficiency defined as AST/ALT levels \>2.5 above normal upper limits.
• On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment
• Prisoner.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Muscular Atrophy; Inflammation; Metabolic Diseases

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Nutritional and Metabolic Diseases

Study Officials

• Neeraj Badjatia, MD MSc

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeraj Badjatia, MD MSc

CONTACT

4103284515; nbadjatia@umm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 28, 2017
• Study Start: December 1, 2017
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)