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Dietary Supplement

NMES + High Protein for Brain Hemorrhage Recovery

N/A

Recruiting

Led By Neeraj Badjatia, MD MSc

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Being diagnosed with aneurysmal SAH

Aneurysmal repair within 48 hours of ictus

Must not have

Presence of a neuromuscular disorder

Diagnosis of chronic renal insufficiency or acute kidney injury (GFR < 30 mL/min/1.73m2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a high protein diet and electrical stimulation on patients recovering from a brain hemorrhage, in order to improve outcomes.

Who is the study for?

Adults aged 25-80 with recent aneurysmal subarachnoid hemorrhage (SAH), who've had aneurysm repair within 48 hours, and will stay in intensive care for over 72 hours. Participants should have a certain severity of SAH but not be too unwell or have conditions like severe kidney issues, muscle disorders, active cancer, or allergies to whey protein.

What is being tested?

The trial is testing if early use of neuromuscular electrical stimulation (NMES) and high-protein supplements can help adults after SAH by improving muscle mass and reducing inflammation compared to standard nutrition and mobilization treatments. It's a prospective study matching patients by age and severity.

What are the potential side effects?

Potential side effects may include discomfort from the NMES device, possible digestive issues due to high protein intake, especially in individuals with pre-existing digestive problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a brain aneurysm that has bled.

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I had surgery to repair an aneurysm within 2 days of its detection.

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My condition after a brain hemorrhage is serious but not critical.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a disorder that affects my muscles and nerves.

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My kidney function is low (GFR < 30).

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I have been diagnosed with an inflammatory disorder.

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My SAH is due to trauma or a specific health condition.

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I currently have active cancer.

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My liver enzymes are more than 2.5 times the normal limit.

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I have experienced weakness or stiffness in my legs within 2 days of an injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: NMES onlyExperimental Treatment1 Intervention

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

Group II: HPRO onlyExperimental Treatment1 Intervention

Patients will receive HPRO three times daily during study period

Group III: HPRO + NMESExperimental Treatment2 Interventions

Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.

Group IV: Standard of CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neuromuscular Electrical Stimulation (NMES)

2018

Completed Phase 2

~170

0 / 10Eligibility criteria met