CClinicalTrials.gg
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

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

Who can participate

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

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. . 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.
04

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.

05

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

06

Study locations

1 of 1 sites recruiting
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03201094
Lead sponsor
University of Maryland, Baltimore
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 ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion