Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-02 @ 4:58 AM
Study NCT ID:
NCT05287958
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of an Electrical Impedance Tomography Device for Pulmonary Function Testing in ALS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-13', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of EIT and PFT measures', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'A correlation coefficient (-1 to +1) will be used'}], 'secondaryOutcomes': [{'measure': 'Assessing differences in lung function images in healthy versus ALS cohorts as generated with EIT', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Correlation coefficient (-1 to +1) will be used to compare regions of interest'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ALS']}, 'descriptionModule': {'briefSummary': 'This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients. The study will enroll patients with ALS in one cohort and healthy volunteers in a second cohort that will both undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure.', 'detailedDescription': 'This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients.\n\nFor both Cohort I and II, subject participation will require two visits (initial and 3-4 month follow up), which are expected to last approximately 30 minutes. Subjects will undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure. The actual EIT imaging will last for 10 to 15 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients clinically diagnosed with ALS', 'healthyVolunteers': True, 'eligibilityCriteria': 'Cohort I\n\nInclusion Criteria:\n\n1. ALS patients able to perform PFT.\n2. ALS patients recommended for PFT.\n3. Subjects capable of giving written informed consent.\n4. Adult, age ≥ 18 years old.\n\nExclusion Criteria:\n\n1. Serious psychiatric illnesses.\n2. Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.\n3. Skin lesions at chest belt placement sites.\n4. Pregnant women.\n5. Patients with primary lung disease, at the discretion of the Investigator.\n\nCohort II\n\n1\\. Subjects capable of giving written informed consent; 2. Subjects capable of performing a PFT; 3. Adult, age ≥ 18 years old 10.2.2 Exclusion Criteria\n\n1. Serious psychiatric illnesses.\n2. Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.\n3. Skin lesions at chest belt placement sites.\n4. Pregnant women.\n5. Subjects with primary lung disease, at the discretion of the Investigator.'}, 'identificationModule': {'nctId': 'NCT05287958', 'briefTitle': 'Feasibility of an Electrical Impedance Tomography Device for Pulmonary Function Testing in ALS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Quantitative Pulmonary Function Testing in ALS Patients', 'orgStudyIdInfo': {'id': '2020C-001010'}, 'secondaryIdInfos': [{'id': 'R21NS118434', 'link': 'https://reporter.nih.gov/quickSearch/R21NS118434', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'While no intervention or investigational agent will be used in this study, an EIT system will be used, which is a Non-Significant Risk Device.', 'interventionNames': ['Diagnostic Test: EIT']}, {'label': 'ALS', 'description': 'While no intervention or investigational agent will be used in this study, an EIT system will be used, which is a Non-Significant Risk Device.', 'interventionNames': ['Diagnostic Test: EIT']}], 'interventions': [{'name': 'EIT', 'type': 'DIAGNOSTIC_TEST', 'description': 'EIT comprises a chest belt that is connected to a computer via a universal serial bus (USB) or an Ethernet cable. The chest belt captures EIT data, which is transmitted via the USB or Ethernet cable to the computer. Tomography-like impedance images of the lungs are computed and displayed on the computer. The impedance images will be used to evaluate lung recruitment and other pulmonary function parameters that are currently measured using standard-of-care PFT devices.', 'armGroupLabels': ['ALS', 'Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Seward Rutkove, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Department of Neurology', 'investigatorFullName': 'Seward Rutkove', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}