Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-10 @ 6:39 AM
Study NCT ID:
NCT02928159
Status:
COMPLETED
Last Update Posted:
2016-10-10
First Post:
2016-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Pulse Amplitude Seizure Therapy (LAP-ST Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2016-10-05', 'studyFirstSubmitQcDate': '2016-10-06', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility (by successfully inducing therapeutic seizures during LAP-ST course)', 'timeFrame': 'From first to last session of LAP-ST course (average approximately 2 weeks)', 'description': 'Measured by: the elicitation of therapeutic seizure in the brain and assessed by using EEG'}], 'secondaryOutcomes': [{'measure': 'Memory (cognitive side effects)', 'timeFrame': 'From Baseline to end of acute course (average 2 weeks)', 'description': 'Measured by: Mini Mental State Examination'}, {'measure': 'Time to reorientation', 'timeFrame': 'From Baseline to end of acute course (average 2 weeks)', 'description': 'Measured by: Time to Orientation Test'}, {'measure': 'Efficacy', 'timeFrame': 'From Baseline to end of acute course (average 2 weeks)', 'description': 'Montgomery-Åsberg Depression Rating Scale (MADRS) for depressive episodes of mood disorders'}, {'measure': 'Efficacy', 'timeFrame': 'From Baseline to end of acute course (average 2 weeks)', 'description': 'Brief Psychiatric Rating Scale (BPRS) for psychotic disorders'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low Pulse Amplitude Seizure Therapy', 'Electroconvulsive Therapy', 'Low Pulse Amplitude Electroconvulsive Therapy', 'Low Pulse Amplitude ECT', 'LAP', 'LAP-ST', 'ECT', 'Mood disorders', 'Psychotic disorders'], 'conditions': ['Mood Disorders', 'Schizophrenia Spectrum and Other Psychotic Disorders']}, 'referencesModule': {'references': [{'pmid': '28667887', 'type': 'DERIVED', 'citation': 'Youssef NA, Sidhom E. Feasibility, safety, and preliminary efficacy of Low Amplitude Seizure Therapy (LAP-ST): A proof of concept clinical trial in man. J Affect Disord. 2017 Nov;222:1-6. doi: 10.1016/j.jad.2017.06.022. Epub 2017 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).', 'detailedDescription': 'This is hypothesized to increase stimulation focality, thus minimizing cognitive side effects compared to conventional ECT. The study will enroll 22 patients recruited from the Behman Hospital, Cairo, Egypt. Patients referred to ECT service in the Behman Hospital who are clinically indicated to do ECT for major depressive episode of a mood disorder or psychotic episode of a primary psychotic disorder will be approached. Eligible participants who signed informed consent will be included to receive a course of Right Unilateral Ultrabrief LAP-ST.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ECT clinically indicated\n2. Males or females over 22 to 80 years of age\n3. Use of effective method of birth control for women of child-bearing capacity\n4. Patient is medically stable\n5. Capacity of patient to fully participate in the informed consent process as evaluated by their clinician\n\nExclusion Criteria:\n\n1. Current unstable or serious medical condition, or any co-morbid medical condition that substantially increases the risks of ECT\n2. History of conditions that may make ECT unsafe such as metal in the head, or a skull defect\n3. Female patients who are currently pregnant or plan to be pregnant during the study'}, 'identificationModule': {'nctId': 'NCT02928159', 'briefTitle': 'Low Pulse Amplitude Seizure Therapy (LAP-ST Study)', 'organization': {'class': 'OTHER', 'fullName': 'Behman Hospital'}, 'officialTitle': 'Low Pulse Amplitude Seizure Therapy (LAP-ST Study)', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Pulse Amplitude Seizure Therapy', 'description': 'Course of Right Unilateral Ultrabrief LAP-ST using Mecta spectrum 5000Q Device.', 'interventionNames': ['Device: Mecta spectrum 5000Q device']}], 'interventions': [{'name': 'Mecta spectrum 5000Q device', 'type': 'DEVICE', 'description': 'LAP-ST and Right Unilateral (RUL) electrode placement.', 'armGroupLabels': ['Low Pulse Amplitude Seizure Therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nagy A. Youssef', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Georgia, Augusta University'}, {'name': 'Emad Sidhom', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Behman Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Behman Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Emad Sidhom', 'investigatorAffiliation': 'Behman Hospital'}}}}