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RecruitingNCT03201094Updated Sep 4, 2026

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

An interventional study of Neuromuscular Electrical Stimulation (NMES) and High Protein Supplementation in Subarachnoid Hemorrhage, Muscle Atrophy and Inflammation, sponsored by University of Maryland, Baltimore. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2017; still recruiting 8 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Subarachnoid Hemorrhage
  • Muscle Atrophy
  • Inflammation
  • Nutritional and Metabolic Disease
03

In context

Subarachnoid Hemorrhage

510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.

This study's planned enrollment of 30 is below the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.

Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. . \< 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
  10. . Diagnosis of an inflammatory disorder
  11. . Presence of a neuromuscular disorder
  12. . Diagnosis of chronic renal insufficiency or acute kidney injury ( \< 30 mL/min/1.73m2)
  13. . Hepatic insufficiency defined as /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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Standard of Care

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

  • Experimental
    HPRO + NMES

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

    Device: Neuromuscular Electrical Stimulation (NMES) · Dietary Supplement: High Protein Supplementation

  • Experimental
    NMES only

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

    Device: Neuromuscular Electrical Stimulation (NMES)

  • Experimental
    HPRO only

    Patients will receive HPRO three times daily during study period

    Dietary Supplement: High Protein Supplementation

Interventions

  • DeviceNeuromuscular Electrical Stimulation (NMES)

    Neuromuscular electrical stimulation twice daily during study period.

  • Dietary supplementHigh Protein Supplementation

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03201094
Responsible party
Neeraj Badjatia (Professor of Neurology, University of Maryland, Baltimore) — Principal investigator
First posted
Jun 28, 2017
Start date
Dec 1, 2017
Primary completion
Sep 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Sep 4, 2026

Study contacts

Neeraj Badjatia, MD MSc
Contact
nbadjatia@umm.edu
4103284515
Neeraj Badjatia, MD MSc
principal investigator · University of Maryland, Baltimore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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