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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 belowSelect...
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:Select...
I have a disorder that affects my muscles and nerves.
Select...
My kidney function is low (GFR < 30).
Select...
I have been diagnosed with an inflammatory disorder.
Select...
My SAH is due to trauma or a specific health condition.
Select...
I currently have active cancer.
Select...
My liver enzymes are more than 2.5 times the normal limit.
Select...
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
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
~140
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
711 Previous Clinical Trials
379,222 Total Patients Enrolled
2 Trials studying Subarachnoid Hemorrhage
5,015 Patients Enrolled for Subarachnoid Hemorrhage
Neeraj Badjatia, MD MScPrincipal Investigator - University of Maryland, Baltimore
University of Maryland, College Park
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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