Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-04-17 @ 12:46 AM
Study NCT ID:
NCT01941251
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2013-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigated αTMS in Treatment-resistant Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2013-09-09', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF)', 'timeFrame': 'at baseline, 1 week after treatment', 'description': 'change in P-/S-BDNF levels'}], 'primaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'at baseline,5 days after treatment, 3 months after treatment', 'description': 'change in PANSS total, positive, negative and general psychopathology sum score'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression - Improvement scale (CGI-I)', 'timeFrame': 'at 5 days after treatment, 3 months after treatment', 'description': "change in patient's illness relative to baseline state"}, {'measure': 'Neuropsychology test battery', 'timeFrame': 'at baseline, 5 days after treatment, 3 months after treatment', 'description': 'Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transcranial Magnetic Stimulation', 'Repetitive Transcranial Magnetic Stimulation', 'Schizophrenia', 'Schizoaffective Disorder', 'Treatment', 'Negative Symptoms', 'Positive Symptoms', 'TMS', 'rTMS'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '38428970', 'type': 'DERIVED', 'citation': 'Tuppurainen H, Maatta S, Kononen M, Julkunen P, Kautiainen H, Hyvarinen S, Vaurio O, Joensuu M, Vanhanen M, Aho-Mustonen K, Mervaala E, Tiihonen J. Navigated and individual alpha-peak-frequency-guided transcranial magnetic stimulation in male patients with treatment-refractory schizophrenia. J Psychiatry Neurosci. 2024 Mar 1;49(2):E87-E95. doi: 10.1503/jpn.230063. Print 2024 Jan-Feb.'}]}, 'descriptionModule': {'briefSummary': 'Since 1990s, stimulation of prefrontal cortex (PFC) has shown therapeutic effects on auditory hallucinations as well as negative symptoms of schizophrenia. However, previous studies have reported mixed or negative results. Majority of the repetitive transcranial magnetic stimulation (rTMS) studies to date has set the target of cortical stimulation based on scalp site. Recently introduced method, navigated transcranial magnetic stimulation (nTMS) integrates the individual MRI data, and thus allows more precise targeting on brain cortical regions enhancing the efficacy of rTMS. Previous EEG studies have suggested reduced alpha band activity in patients with schizophrenia. Some recent studies using alpha (α) EEG guided TMS for treating positive and negative symptoms of schizophrenia have demonstrated promising results.\n\nThe aim of the study is to investigate the efficacy of navigated individualized αTMS in treatment-resistant patients with schizophrenia. Approximately fifty patients with DSM-IV schizophrenia will be enrolled in this randomized, double-blind, sham-controlled study. The patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex (DLPFC), as adjunctive therapy, for 3 weeks. We assess patients via the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) and neurocognitive test battery at baseline, 5 days after and 3 months after treatment. Serum and plasma levels of brain derived neurotrophic factor (BDNF) are assayed at pre and post treatment weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male righthanded inpatients, 18 to 64 years of age\n* The diagnosis of Schizophrenia or Schizoaffective Disorder according to DSM-IV\n* Capacity and willingness to give informed consent\n* Patient is treatment-resistant, CGI-S 4 or more\n* Patient is not requiring a change in antipsychotic medication 2 weeks prior to or during treatment\n* No foreseeable changes in patient's smoking habits during treatment\n\nExclusion Criteria:\n\n* Serious somatic illness\n* Progressive neurological illness, recent brain damage (less than 3 months ago) or sequela of serious brain damage\n* Unstable epilepsy\n* Electro convulsive therapy (ECT) less than 3 months prior to treatment"}, 'identificationModule': {'nctId': 'NCT01941251', 'acronym': 'nTMS_NS', 'briefTitle': 'Navigated αTMS in Treatment-resistant Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Niuvanniemi Hospital'}, 'officialTitle': 'Navigated Alpha Frequency Transcranial Magnetic Stimulation (αTMS) in Treatment-resistant Schizophrenia', 'orgStudyIdInfo': {'id': '932012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Navigated individualized αTMS', 'description': 'navigated Transcranial Magnetic Stimulation', 'interventionNames': ['Device: navigated Transcranial Magnetic Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham TMS', 'description': 'navigated Transcranial Magnetic Stimulation using sham coil', 'interventionNames': ['Device: navigated Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'navigated Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'otherNames': ['TMS', 'rTMS'], 'description': '* individualized α frequency\n* left DLPFC 110% motor threshold (MT)\n* 13-15 sessions for 3 weeks', 'armGroupLabels': ['Navigated individualized αTMS']}, {'name': 'navigated Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'otherNames': ['TMS', 'rTMS'], 'description': '\\- placebo treatment: sham coil', 'armGroupLabels': ['Sham TMS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuopio', 'country': 'Finland', 'facility': 'Niuvanniemi Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Heli Tuppurainen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Niuvanniemi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Niuvanniemi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Heli Tuppurainen', 'investigatorAffiliation': 'Niuvanniemi Hospital'}}}}