Impact of NMES and HPRO on Recovery After SAH- Pilot Study
Primary Purpose
Subarachnoid Hemorrhage, Muscle Atrophy, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation (NMES)
High Protein Supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage
Eligibility Criteria
Inclusion 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.
Exclusion criteria:
- . 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.
Sites / Locations
- University of Maryland Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Standard of Care
HPRO + NMES
NMES only
HPRO only
Arm Description
Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.
Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.
Patients will undergo two 30 minute NMES sessions per day during study period.
Patients will receive HPRO three times daily during study period
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03201094
First Posted
June 23, 2017
Last Updated
May 16, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03201094
Brief Title
Impact of NMES and HPRO on Recovery After SAH- Pilot Study
Official Title
Impact of Neuromuscular Stimulation and High Protein Nutritional Supplementation on Long-term Recovery After Aneurysmal Subarachnoid Hemorrhage.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Muscle Atrophy, Inflammation, Nutritional and Metabolic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.
Arm Title
HPRO + NMES
Arm Type
Experimental
Arm Description
Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.
Arm Title
NMES only
Arm Type
Experimental
Arm Description
Patients will undergo two 30 minute NMES sessions per day during study period.
Arm Title
HPRO only
Arm Type
Experimental
Arm Description
Patients will receive HPRO three times daily during study period
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation (NMES)
Intervention Description
Neuromuscular electrical stimulation twice daily during study period.
Intervention Type
Dietary Supplement
Intervention Name(s)
High Protein Supplementation
Intervention Description
High protein supplementation with whey protein shakes taken three times a day during study period.
Primary Outcome Measure Information:
Title
Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period.
Description
Change in the muscle layer thickness of the quadriceps muscle as measured by ultrasound.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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.
Exclusion criteria:
. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neeraj Badjatia, MD MSc
Phone
4103284515
Email
nbadjatia@umm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeraj Badjatia, MD MSc
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeraj Badjatia, MD MS
Phone
410-328-4515
Email
nbadjatia@umm.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of NMES and HPRO on Recovery After SAH- Pilot Study
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