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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,626 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

High Protein Supplementation (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03201094 — N/A

Subarachnoid Hemorrhage Clinical Trial 2023: High Protein Supplementation Highlights & Side Effects. Trial Name: NCT03201094 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have recruitment efforts for this clinical trial resumed?

"Absolutely. According to the information on clinicaltrials.gov, this experiment is still seeking participants since it was posted in December 1st 2017 and recently updated in April 29th 2022. The trial expects to have 30 individuals from one centre joining its ranks."

Answered by AI

Can you provide an estimate of the number of participants in this trial?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is actively recruiting participants since its initial posting in December 2017 and last update in April 2022. The projected number of patients needed for the study is 30 across a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Neeraj Badjatia 2017. "Impact of NMES and HPRO on Recovery After SAH- Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03201094.

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