Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT03201094
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2017-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of NMES and HPRO on Recovery After SAH- Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2017-06-23', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period.', 'timeFrame': '14 days', 'description': 'Change in the muscle layer thickness of the quadriceps muscle as measured by ultrasound.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage', 'Muscle Atrophy', 'Inflammation', 'Nutritional and Metabolic Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. . Being diagnosed with aneurysmal SAH\n2. . Aneurysmal repair within 48 hours of ictus.\n3. . Age between 25 and 80 years old. (\\>=25 years old and \\<=80 years old)\n4. . Expected stay in the NCCU \\> 72 hours.\n5. . Admission Hunt Hess Grade \\>=2.\n6. modified Fisher score \\>1.\n\nExclusion criteria:\n\n1. . Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;\n2. . Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;\n3. . Unlikely to remain in the ICU for more than 7 days;\n4. . Body mass index \\< 15 or \\>40 kg/m2;\n5. . Allergy to whey protein;\n6. . Evidence of lower extremity paresis or spasticity within 48 hours of injury\n7. . Pre-morbid modified Rankin Score \\>1.\n8. . Known pregnancy\n9. . Presence of active malignancy\n10. . Diagnosis of an inflammatory disorder\n11. . Presence of a neuromuscular disorder\n12. . Diagnosis of chronic renal insufficiency or acute kidney injury (GFR \\< 30 mL/min/1.73m2)\n13. . Hepatic insufficiency defined as AST/ALT levels \\>2.5 above normal upper limits.\n14. . On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment\n15. . Prisoner.'}, 'identificationModule': {'nctId': 'NCT03201094', 'briefTitle': 'Impact of NMES and HPRO on Recovery After SAH- Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Impact of Neuromuscular Stimulation and High Protein Nutritional Supplementation on Long-term Recovery After Aneurysmal Subarachnoid Hemorrhage.', 'orgStudyIdInfo': {'id': 'HP-00074174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.'}, {'type': 'EXPERIMENTAL', 'label': 'HPRO + NMES', 'description': 'Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.', 'interventionNames': ['Device: Neuromuscular Electrical Stimulation (NMES)', 'Dietary Supplement: High Protein Supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'NMES only', 'description': 'Patients will undergo two 30 minute NMES sessions per day during study period.', 'interventionNames': ['Device: Neuromuscular Electrical Stimulation (NMES)']}, {'type': 'EXPERIMENTAL', 'label': 'HPRO only', 'description': 'Patients will receive HPRO three times daily during study period', 'interventionNames': ['Dietary Supplement: High Protein Supplementation']}], 'interventions': [{'name': 'Neuromuscular Electrical Stimulation (NMES)', 'type': 'DEVICE', 'description': 'Neuromuscular electrical stimulation twice daily during study period.', 'armGroupLabels': ['HPRO + NMES', 'NMES only']}, {'name': 'High Protein Supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High protein supplementation with whey protein shakes taken three times a day during study period.', 'armGroupLabels': ['HPRO + NMES', 'HPRO only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Neeraj Badjatia, MD MS', 'role': 'CONTACT', 'email': 'nbadjatia@umm.edu', 'phone': '4103284515'}], 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Neeraj Badjatia, MD MSc', 'role': 'CONTACT', 'email': 'nbadjatia@umm.edu', 'phone': '4103284515'}], 'overallOfficials': [{'name': 'Neeraj Badjatia, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Neeraj Badjatia', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}