Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:52 AM
Study NCT ID:
NCT07428460
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, outcome assessors and treaters are blinded to treatment assignment. Care providers are blinded where feasible based on study procedures. Measures are in place to preserve blinding throughout the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Avolition/Apathy Subscale Score', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Change in score on the Avolition/Apathy subscale of the Scale for the Assessment of Negative Symptoms (SANS). The SANS Avolition/Apathy subscale ranges from 0 to 25, with higher scores indicating greater negative symptom severity.'}, {'measure': 'Change in Scale for the Assessment of Negative Symptoms Total Score', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Change in total score on the Scale for the Assessment of Negative Symptoms (SANS). Total scores range from 0 to 125, with higher scores indicating greater negative symptom severity.'}, {'measure': 'Change in Brief Negative Symptom Scale Total Score', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Change in total score on the Brief Negative Symptom Scale (BNSS). Total scores range from 0 to 78, with higher scores indicating greater negative symptom severity.'}, {'measure': 'Effect of Targeting Method on Negative Symptoms', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Difference in change in negative symptom severity between targeting methods, as measured by negative symptom outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change in Affective Processing', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Change in affective processing as measured by performance on a behavioural task assessing conditioned hallucinations related to valenced auditory information.'}, {'measure': 'Change in Social Appraisal', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Change in social appraisal and belief updating as measured by performance on a behavioral task assessing social inference and valuation.'}, {'measure': 'Change in Cognitive Performance', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Change in cognitive performance as measured by an automated cognitive battery assessing attention, processing speed, working memory, verbal memory, verbal fluency, and executive function.'}, {'measure': 'Change in Montgomery-Åsberg Depression Rating Scale Score', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Change in score on the Montgomery-Åsberg Depression Rating Scale. Total scores range from 0 to 60, with higher scores indicating greater depressive symptom severity.'}, {'measure': 'Change in Calgary Depression Scale for Schizophrenia Score', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Change in score on the Calgary Depression Scale for Schizophrenia. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.'}, {'measure': 'Change in Social and Occupational Functioning Assessment Scale Score', 'timeFrame': 'Baseline to 1 week, 1 month, and 3 months post-treatment', 'description': 'Change in score on the Social and Occupational Functioning Assessment Scale. Scores range from 0 to 100, with higher scores indicating better functioning.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Negative symptoms', 'Neuromodulation therapy', 'Non-invasive brain stimulation', 'Accelerated treatment', 'Schizophrenia spectrum disorders', 'TMS', 'Transcranial Magnetic Stimulation', 'Outpatient treatment'], 'conditions': ['Schizophrenia and Predominant Negative Symptoms']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if an accelerated form of neuromodulation therapy can help improve negative symptoms of schizophrenia. Negative symptoms can include low motivation, reduced emotional expression, and difficulty with social interaction. The study will also look at how safe and tolerable this treatment is when given over a short period of time.\n\nParticipants will be randomly assigned to receive either active neuromodulation therapy or sham (placebo) stimulation. The study will also compare two different ways of choosing where to place the stimulation.\n\nWe want to learn whether this accelerated treatment approach is safe and feasible for people with schizophrenia, whether negative symptoms improve after treatment, and whether the way the stimulation site is chosen affects outcomes\n\nParticipants will be asked to complete clinical interviews and questionnaires, undergo a brain scan, receive neuromodulation therapy or sham stimulation over five consecutive days, and attend follow-up visits after treatment\n\nThis study is being conducted at three hospitals in Canada and is designed to help plan larger studies in the future.', 'detailedDescription': 'Negative symptoms of schizophrenia, including diminished motivation, reduced emotional expression, and impaired social functioning, are a major contributor to long-term disability and remain inadequately treated by existing interventions. Repetitive transcranial magnetic stimulation targeting the left dorsolateral prefrontal cortex has demonstrated potential benefit for negative symptoms, but conventional treatment schedules often require multiple weeks of daily sessions, which may limit feasibility in this population.\n\nAccelerated neuromodulation therapy delivers multiple stimulation sessions per day over a condensed time period and may improve accessibility, adherence, and tolerability. This pilot study evaluates an accelerated iTBS protocol delivered over five consecutive days in individuals with schizophrenia spectrum disorders who exhibit clinically significant negative symptoms.\n\nParticipants are randomized to receive either active neuromodulation therapy or sham stimulation. In addition, the study evaluates two approaches to stimulation targeting. Targeting approach is assigned according to study procedures designed to preserve participant and rater blinding.\n\nAll participants undergo baseline clinical, behavioral, and functional assessments, followed by the accelerated treatment protocol and post-treatment follow-up assessments. Primary outcomes focus on changes in negative symptom severity, while secondary outcomes assess depressive symptoms, functional outcomes, and task-based behavioral measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder\n* Duration of illness ≥ 6 months\n* Clinically significant negative symptoms\n* Must have been on a stable pharmacological treatment for at least 4 weeks before entering the study\n* Clinicians will confirm that patients' negative and positive symptoms have been stable per their clinical opinion for at least 3 months.\n* Participants must be able to provide informed consent\n* Ability to undergo MRI scanning\n\nExclusion Criteria:\n\n* Pregnancy, lactation, or an intrauterine device\n* History of electroconvulsive therapy (ECT) in the past 6 months\n* Use of licit or illicit substances (excluding cannabis) during the week of treatment and in the 24 hours prior to fMRI scans\n* Contraindications for TMS\n* Previous treatment with rTMS\n* Documented history of significant intellectual disability\n* Primary diagnosis of psychotic disorder secondary to a medical condition or substance-induced psychosis."}, 'identificationModule': {'nctId': 'NCT07428460', 'acronym': 'TMSNS', 'briefTitle': 'Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Douglas Mental Health University Institute'}, 'officialTitle': 'Accelerated, Neuronavigated Neuromodulation Therapy for Negative Symptoms of Schizophrenia', 'orgStudyIdInfo': {'id': 'MP-18-2025-1206'}, 'secondaryIdInfos': [{'id': '8401470ASMQ', 'type': 'OTHER_GRANT', 'domain': 'Alliance Santé Mentale - Axe Neuromodulation'}, {'id': 'CIHR-8401550', 'type': 'OTHER_GRANT', 'domain': 'CIHR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active iTBS (Neuronavigated Targeting)', 'description': 'Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using neuronavigation-guided targeting.', 'interventionNames': ['Device: Neuronavigated Intermittent Theta Burst Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Active iTBS (BEAM-F3 Targeting)', 'description': 'Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using BEAM-F3 targeting.', 'interventionNames': ['Device: BEAM-F3 Intermittent theta burst stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham iTBS', 'description': 'Participants receive sham iTBS over five consecutive days (ten sessions/day) using the same session structure and procedures as active treatment.', 'interventionNames': ['Device: Sham Intermittent Theta Burst Stimulation']}], 'interventions': [{'name': 'Neuronavigated Intermittent Theta Burst Stimulation', 'type': 'DEVICE', 'description': "Neuronavigated intermittent theta burst stimulation (iTBS) is delivered using a transcranial magnetic stimulation device with a figure-of-eight coil targeting the left dorsolateral prefrontal cortex. Individualized stimulation targets are identified using functional MRI data and are imported into a neuronavigation system to guide coil positioning and orientation throughout treatment.\n\nTreatment is delivered over five consecutive days using an accelerated schedule consisting of ten stimulation sessions per day. Each iTBS session is delivered at an intensity corresponding to 110% of the participant's resting motor threshold, with stimulation intensity adjusted for individual cortical depth.", 'armGroupLabels': ['Active iTBS (Neuronavigated Targeting)']}, {'name': 'BEAM-F3 Intermittent theta burst stimulation', 'type': 'DEVICE', 'description': "BEAM-F3 intermittent theta burst stimulation (iTBS) is delivered using a transcranial magnetic stimulation device with a figure-of-eight coil targeting the left dorsolateral prefrontal cortex. Stimulation targets are identified according to the BEAM-F3 procedure.\n\nTreatment is delivered over five consecutive days using an accelerated schedule consisting of ten stimulation sessions per day. Each iTBS session is delivered at an intensity corresponding to 110% of the participant's resting motor threshold, with stimulation intensity adjusted for individual cortical depth.", 'armGroupLabels': ['Active iTBS (BEAM-F3 Targeting)']}, {'name': 'Sham Intermittent Theta Burst Stimulation', 'type': 'DEVICE', 'description': 'Sham intermittent theta burst stimulation is delivered using a transcranial magnetic stimulation device with a figure-of-eight coil positioned over the left dorsolateral prefrontal cortex. Coil placement, session structure, and treatment schedule are identical to those used for active stimulation.\n\nTreatment is delivered over five consecutive days using an accelerated schedule consisting of ten stimulation sessions per day. Sham stimulation is administered using procedures designed to mimic the experience of active iTBS without producing therapeutic cortical stimulation.', 'armGroupLabels': ['Sham iTBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1N 3M5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stéphane Potvin, PhD', 'role': 'CONTACT', 'email': 'stephane.potvin@umontrela.ca', 'phone': '(514) 251-4015'}, {'name': 'Stéphane Potvin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Universitaire en Santé Mentale de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1J 2G3', 'city': 'Québec', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olivier Roy Roy, MD, MSc, PhD, FRCPC', 'role': 'CONTACT', 'email': 'olivier.roy@cervo.ulaval.ca', 'phone': '418-663-5000', 'phoneExt': '24615'}, {'name': 'Olivier Roy, MD, MSc, PhD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut universitaire de santé mentale de Québec - Centre de recherche CERVO', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'H4H 1R3', 'city': 'Verdun', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ashley Choucroun', 'role': 'CONTACT', 'email': 'ashley.choucroun.comtl@ssss.gouv.qc.ca', 'phone': '5146593488'}, {'name': 'David Benrimoh, MD.CM., MSc., MSc., FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QC', 'geoPoint': {'lat': 45.46005, 'lon': -73.57058}}], 'centralContacts': [{'name': 'Ashley S. Choucroun', 'role': 'CONTACT', 'email': 'ashley.choucroun.comtl@ssss.gouv.qc.ca'}], 'overallOfficials': [{'name': 'David Benrimoh, MD.CM., MSc., MSc., FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University, Department of Psychiatry'}, {'name': 'Olivier Roy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de recherche CERVO - Université Laval'}, {'name': 'Stéphane Potvin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Universitaire en Santé Mentale de Montréal'}, {'name': 'Lena Palaniyappan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Douglas Mental Health Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Douglas Mental Health University Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre de recherche CERVO', 'class': 'UNKNOWN'}, {'name': 'Magnus Medical', 'class': 'INDUSTRY'}, {'name': "Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'NeuroPsychiatrist', 'investigatorFullName': 'David Benrimoh', 'investigatorAffiliation': 'Douglas Mental Health University Institute'}}}}