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

NCT ID: NCT03201094

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2026-10-30

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.

Conditions

Subarachnoid Hemorrhage; Muscle Atrophy; Inflammation; Nutritional and Metabolic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

HPRO + NMES

Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation (NMES)

Intervention Type: DEVICE

Neuromuscular electrical stimulation twice daily during study period.

High Protein Supplementation

Intervention Type: DIETARY_SUPPLEMENT

High protein supplementation with whey protein shakes taken three times a day during study period.

NMES only

Patients will undergo two 30 minute NMES sessions per day during study period.

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation (NMES)

Intervention Type: DEVICE

Neuromuscular electrical stimulation twice daily during study period.

HPRO only

Patients will receive HPRO three times daily during study period

Group Type: EXPERIMENTAL

High Protein Supplementation

Intervention Type: DIETARY_SUPPLEMENT

High protein supplementation with whey protein shakes taken three times a day during study period.

Interventions

Neuromuscular Electrical Stimulation (NMES)

Neuromuscular electrical stimulation twice daily during study period.

Intervention Type: DEVICE

High Protein Supplementation

High protein supplementation with whey protein shakes taken three times a day during study period.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. . Being diagnosed with aneurysmal SAH

2. . Aneurysmal repair within 48 hours of ictus.

3. . Age between 25 and 80 years old. (>=25 years old and <=80 years old)

4. . Expected stay in the NCCU > 72 hours.

5. . Admission Hunt Hess Grade >=2.

6. modified Fisher score >1.

Exclusion Criteria

1. . Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;

2. . Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;

3. . Unlikely to remain in the ICU for more than 7 days;

4. . Body mass index < 15 or >40 kg/m2;

5. . Allergy to whey protein;

6. . Evidence of lower extremity paresis or spasticity within 48 hours of injury

7. . Pre-morbid modified Rankin Score >1.

8. . Known pregnancy

9. . Presence of active malignancy

10. . Diagnosis of an inflammatory disorder

11. . Presence of a neuromuscular disorder

12. . Diagnosis of chronic renal insufficiency or acute kidney injury (GFR < 30 mL/min/1.73m2)

13. . Hepatic insufficiency defined as AST/ALT levels >2.5 above normal upper limits.

14. . On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment

15. . Prisoner.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Neeraj Badjatia

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neeraj Badjatia, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Neeraj Badjatia, MD MSc

Role: CONTACT

nbadjatia@umm.edu

4103284515

Facility Contacts

Neeraj Badjatia, MD MS

Role: primary

nbadjatia@umm.edu

4103284515

Other Identifiers

HP-00074174

Identifier Type: -

Identifier Source: org_study_id