Last reviewed · How we verify

NCT03201094

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

Recruiting now NA Last updated 15 October 2024
What this trial tests

NA trial testing Neuromuscular Electrical Stimulation (NMES) in Subarachnoid Hemorrhage in 30 participants. Currently enrolling.

Timeline
1 December 2017
Primary endpoint
31 May 2026
30 October 2026

Quick facts

Lead sponsorUniversity of Maryland, Baltimore
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment30
Start date1 December 2017
Primary completion31 May 2026
Estimated completion30 October 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Maryland, Baltimore

Who can join

18 and older, any sex, with Subarachnoid Hemorrhage or Muscle Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Neuromuscular Electrical Stimulation and High-Protein Supplementation After Subarachnoid Hemorrhage: A Single-Center Phase 2 Randomized Clinical Trial.
    Badjatia N, Sanchez S, Judd G, Hausladen R, et al · · 2021 · cited 24× · PMID 33150572 · DOI 10.1007/s12028-020-01138-4
  2. Identification of metabolites associated with preserved muscle volume after aneurysmal subarachnoid hemorrhage due to high protein supplementation and neuromuscular electrical stimulation.
    Gusdon AM, Savarraj JPJ, Feng D, Starkman A, et al · · 2024 · cited 5× · PMID 38956192 · DOI 10.1038/s41598-024-64666-5
  3. 17th Annual Meeting, Neurocritical Care Society, October 15-18, 2019, Vancouver, Canada.
    · 2019 · cited 1× · PMID 31576484 · DOI 10.1007/s12028-019-00857-7

Verify or expand the search:

Other trials of Neuromuscular Electrical Stimulation (NMES)

Trials testing the same drug.

Other recruiting trials for Subarachnoid Hemorrhage

Currently open trials in the same condition.

Other University of Maryland, Baltimore trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03201094.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing