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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

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

nbadjatia@umm.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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