Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT05337904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-29
First Post:
2022-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090663', 'term': 'Schizophrenia, Treatment-Resistant'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A clinical trial with four periods will be performed: pre-treatment, Intervention and follow-up, Cross-over period, and Recoveryoriented intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale for Schizophrenia (PANSS)', 'timeFrame': 'Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)', 'description': "Scale to assess changes in schizophrenia' symptoms"}], 'secondaryOutcomes': [{'measure': 'Questionnaire about the Process of Recovery (QPR)', 'timeFrame': 'Changes from baseline total score to 1-12 months total scores', 'description': 'Scale to assess personal recovery changes'}, {'measure': 'Rosenberg Self-Esteem Scale (RSES)', 'timeFrame': 'Changes from baseline total score to 12 months total scores', 'description': "Scale to assess a person's global self-esteem"}, {'measure': 'Herth Hope Index (HHI)', 'timeFrame': 'Changes from baseline total score to 12 months total scores', 'description': 'Scale to assess hope'}, {'measure': 'Internalized stigma of mental illness scale (ISMI)', 'timeFrame': 'Changes from baseline total score to 12 months total scores', 'description': 'Scale to assess insight'}, {'measure': 'Beck Cognitive Insight Scale (BCIS)', 'timeFrame': 'Changes from baseline total score to 12 months total scores', 'description': 'Scale to assess cognitive insight'}, {'measure': 'Personal Beliefs about Illness Questionnaire-Revised (PBIQ-R)', 'timeFrame': 'Changes from baseline total score to 12 months total scores', 'description': 'Scale to assess psychological reactions to psychosis'}, {'measure': 'Trail Making Test (TMT A & B)', 'timeFrame': 'Changes from baseline score to 12 months score.', 'description': 'Scale to assess executive function'}, {'measure': 'Rey Auditory Verbal Learning Test (RAVLT)', 'timeFrame': 'Changes from baseline score to 12 months score.', 'description': 'Scale to assess short-term auditory-verbal memory'}, {'measure': 'F-A-S Test', 'timeFrame': 'Changes from baseline score to 12 months score.', 'description': 'Scale to assess verbal fluency'}, {'measure': 'Wisconsin Card Sorting Test (WCST)', 'timeFrame': 'Changes from baseline score to 12 months score.', 'description': 'Scale to assess cognitive flexibility and abstract reasoning'}, {'measure': 'Personal and Social Performance scale (PSP)', 'timeFrame': 'Changes from baseline score to 1-3 weeks scores and to 1-12 months scores', 'description': 'Scale to assess changes in functioning'}, {'measure': 'EuroQol 5 dimensions-5 levels (EQ-5D-5L)', 'timeFrame': 'Changes from baseline score to 1-12 months scores', 'description': 'Scales to asses the patient quality of life'}, {'measure': 'Client Satisfaction Questionnaire-8 (CSQ-8)', 'timeFrame': 'Changes from baseline score to 12 months score.', 'description': 'Scales to asses the satisfaction with the treatment'}, {'measure': 'Scale for the Assessment of Negative Symptoms (SANS)', 'timeFrame': 'Changes from baseline score to 1-3 weeks scores and to 1-12 months scores', 'description': 'Scales to assess negative symptoms of schizophrenia'}, {'measure': 'Clinical Global Impression - Schizophrenia (CGI-SCH)', 'timeFrame': 'Changes from baseline score to 1-3 weeks scores and to 1-12 months scores', 'description': 'Scale to assess the severity of disorder and the degree of change in patients'}, {'measure': 'Starkstein Apathy Scale (SAS)', 'timeFrame': 'Changes from baseline score to 1-3 weeks scores and to 1-12 months scores', 'description': 'Scale to assess apathy'}, {'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'Changes from baseline score to 1-3 weeks scores and to 1-12 months scores', 'description': 'Scale to assess depression'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Changes from baseline score to 1-3 weeks scores and to 1-12 months scores', 'description': 'Scale to assess anxiety'}, {'measure': 'Global Assessment of Functioning (GAF)', 'timeFrame': 'Changes from baseline score to 1-3 weeks scores and to 1-12 months scores', 'description': 'Scale to rate how serious a mental disorder may be'}, {'measure': 'Side Effect Rating Scale (UKU)', 'timeFrame': 'Changes from baseline score to 1-3 weeks scores and to 1-12 months scores', 'description': 'Scale to rate side effects'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recovery', 'Deep brain stimulation', 'Schizophrenia'], 'conditions': ['Treatment-resistant Schizophrenia', 'Deep Brain Stimulation']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS).', 'detailedDescription': 'The Project aims to improve the efficacy of the first worldwide study of Deep Brain Stimulation (DBS) carried out in our hospital -PI12 / 00042: Deep Brain Stimulation in the treatment of refractory schizophrenia- through the implementation of a white matter tractography approach, which have demonstrated to improve efficacy in other DBS studies .\n\nMoreover, and in line with the National Strategy of Mental Health of the National Health System, this project aims to promote integrated and comprehensive care for patients with mental illness by multidisciplinary teams which includes family care, as we consider it is important to add to the DBS treatment program, a psychological intervention module based on the recovery model. Therefore, the main objectives of the present project are:\n\ni) to optimizethe efficacy and tolerability of DBS in TRS;\n\nii) investigate whether the REFOCUS intervention improves the recovery of patients who are being treated with DBS. To this end, a double-blind, randomized, crossover clinical trial of DBS will be performed for 6 patients with TRS. Patients will be randomized to receive tractography-based target guidance DBS in the anterior cingulate cortex (ACC) or the nucleus accumbens (Nac). The 21 patient previously intervened with DBS (Affective disorders and TRS) and the ones included in this project, will enter into a psychological intervention phase, based on the REFOCUS model'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18-50 years\n* Meet DSM-5 criteria for schizophrenia, with a duration of illness \\< than 15 years.\n* Meet updated TRS criteria.\n* Non-sustained response to electroconvulsive therapy.\n\nExclusion Criteria:\n\n* Contraindications to neurosurgery or DBS\n* Epilepsy or seizures clozapine-induced\n* Suicidal or self-harming behaviour in the last 6 months\n* Other psychiatric disorders (including personality disorders)\n* Significant cognitive impairment (Vocabulary test WAIS IV-TR, IQ \\<70, and SCIP\\<55)\n* Severe medical non-controlled diseases\n* Pregnancy or breastfeeding\n* Substance use disorders (except nicotine)'}, 'identificationModule': {'nctId': 'NCT05337904', 'acronym': 'DBS-R', 'briefTitle': 'Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Deep Brain Stimulation: Towards a Novel Intervention Focused on the Recovery of Patients With Treatment-Resistant Schizophrenia: Randomized, Controlled, Crossover Pilot Study', 'orgStudyIdInfo': {'id': 'IIBSP-ECP-2019-98'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'On-Stimulation', 'description': 'Disease condition is assessed with stimulation turned "on"', 'interventionNames': ['Device: On-Stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Off-Stimulation', 'description': 'Disease condition is assessed with stimulation turned "off"', 'interventionNames': ['Device: Off-Stimulation']}], 'interventions': [{'name': 'On-Stimulation', 'type': 'DEVICE', 'description': 'The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on".', 'armGroupLabels': ['On-Stimulation']}, {'name': 'Off-Stimulation', 'type': 'DEVICE', 'description': 'The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off".', 'armGroupLabels': ['Off-Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Department of Psychiatry. Hospital Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Iluminada Corripio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry. Hospital Santa Creu i Sant Pau'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}