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New treatment option for Subarachnoid Hemorrhage
Official title Impact of NMES and HPRO on Recovery After SAH- Pilot Study
ClinicalTrials.gov ID: NCT03201094
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join if
- . people 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 \ 40 kg/m2;
- . Allergy to whey protein;
- . Evidence of lower extremity paresis or spasticity within 48 hours of injury
See the full eligibility criteria
- . 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.
- . people 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.