Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-29 @ 3:40 PM
Study NCT ID:
NCT06085950
Status:
UNKNOWN
Last Update Posted:
2023-10-17
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-06-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-10-10', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint', 'timeFrame': 'Pre-treatment and Day 5 from start of intervention', 'description': 'MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.'}], 'secondaryOutcomes': [{'measure': 'Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale', 'timeFrame': 'Day 1 to Day 35 from start of intervention', 'description': 'CTCAE are a set of criteria for the standardized classification of adverse effects'}, {'measure': 'Percent change in the Montgomery-Åsberg Depression Scale (MADRS)', 'timeFrame': 'Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention', 'description': 'MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.'}, {'measure': 'Percent change in the Hamilton Rating Scale for Depression (HDRS-17)', 'timeFrame': 'Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention', 'description': 'HDRS-17 is a 17 item questionnaire used to score the severity of depression. Scale range - 0 to 52 with higher score indicative of greater depressive symptomology.'}, {'measure': 'Percent change in the Hamilton Rating Scale for Depression (HDRS-6)', 'timeFrame': 'Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention', 'description': 'HDRS-6 is a 6 item questionnaire used to score the severity of depression. Scale range - 0 to 22 with higher score indicative of greater depressive symptomology.'}, {'measure': 'Percent change in the Inventory of Depressive Symptomatology (IDC-C)', 'timeFrame': 'Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention', 'description': 'IDS-C is a 30 item questionnaire used to score the severity of depression. Scale range - 0 to 90 with higher score indicative of greater depressive symptomology.'}, {'measure': 'Percent change in the Quick Inventory of Depressive Symptomatology (QIDS-SR)', 'timeFrame': 'Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention', 'description': 'QIDS-SR is a 16 item self-administered questionnaire used to score the severity of depression. Scale range - 0 to 27 with higher score indicative of greater depressive symptomology.'}, {'measure': 'Assess the changes in functional connectivity of sgACC after TUS', 'timeFrame': 'Pre-treatment and Day 7 from start of intervention', 'description': 'Comparison of functional connectivity of subgenual cingulate cortex through resting state imaging analysis before / after intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment Resistant Depression']}, 'referencesModule': {'references': [{'pmid': '40311843', 'type': 'DERIVED', 'citation': 'Attali D, Tiennot T, Manuel TJ, Daniel M, Houdouin A, Annic P, Dizeux A, Haroche A, Dadi G, Henensal A, Moyal M, Le Berre A, Paolillo C, Charron S, Debacker C, Lui M, Lekcir S, Mancusi R, Gallarda T, Sharshar T, Sylla K, Oppenheim C, Cachia A, Tanter M, Aubry JF, Plaze M. Deep transcranial ultrasound stimulation using personalized acoustic metamaterials improves treatment-resistant depression in humans. Brain Stimul. 2025 May-Jun;18(3):1004-1014. doi: 10.1016/j.brs.2025.04.018. Epub 2025 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to optimize the protocol for the TUS administration in patients with TRD while gaining an initial impression of treatment efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75 years,\n* Diagnosis of major depressive episode (MDE) as part of major depressive disorder as defined by DSM-5 criteria\n* Severe MDE (HDRS-17\\> 20)\n* Drug resistance to at least two well-conducted antidepressant treatment lines\n* With stable antidepressant treatment for at least 4 weeks before inclusion\n* Benefiting from a social security scheme\n* Having given their consent to participate\n\nExclusion Criteria:\n\n* Psychiatric history other than a mood disorder\n* Neurological history, including epilepsy and intracerebral calcifications\n* History of substance use disorder other than tobacco\n* Contraindication to brain MRI (pacemaker, neurostimulator, injury from metallic shine, …)\n* Compulsory psychiatric care\n* Protected adults, people under legal safeguard\n* Pregnant or breastfeeding woman\n* Women of childbearing age who do not have a negative pregnancy test and are not using contraception'}, 'identificationModule': {'nctId': 'NCT06085950', 'acronym': 'StimulUS', 'briefTitle': 'Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier St Anne'}, 'officialTitle': 'Transcranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial', 'orgStudyIdInfo': {'id': 'D21-P020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens', 'description': 'Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull', 'interventionNames': ['Device: Transcranial Ultrasonic Stimulation prototype']}], 'interventions': [{'name': 'Transcranial Ultrasonic Stimulation prototype', 'type': 'DEVICE', 'description': 'Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation', 'armGroupLabels': ['Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion Plaze, MD, PHD', 'role': 'CONTACT', 'email': 'm.plaze@ghu-paris.fr', 'phone': '0145658720'}, {'name': 'David ATTALI, MD, PHD', 'role': 'CONTACT', 'email': 'd.attali@ghu-paris.fr'}], 'facility': 'GHU Sainte-Anne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Marion PLAZE', 'role': 'CONTACT', 'email': 'm.plaze@ghu-paris.fr', 'phone': '+33 1 45 65 87 20'}, {'name': 'David ATTALI', 'role': 'CONTACT', 'email': 'd.attali@ghu-paris.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier St Anne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}