Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
Study NCT ID:
NCT05262868
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2022-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cornell Scale for Depression in Dementia (CSDD)', 'timeFrame': 'from baseline to day 20', 'description': 'Mood assessment tool'}], 'secondaryOutcomes': [{'measure': 'Montreal Cognitive Assessment (MOCA)', 'timeFrame': 'from baseline to day 20', 'description': 'Cognitive assessment tool'}, {'measure': 'NPI-Q', 'timeFrame': 'from baseline to day 20', 'description': 'Behavioural assessment tool for demented patients'}, {'measure': 'The ratio of patients who completed the study and drop-outs due to non-compliance', 'timeFrame': 'During all the study period', 'description': 'Compliance assessment tool'}, {'measure': 'Possible changes of structural MRI before as compared to after the treatment', 'timeFrame': 'from baseline to day 20', 'description': 'quantitative structural MRI protocol allowing for an optimal segmentation - resolution of grey versus white matter including cortical and sub-cortical brain structures.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavioral and Psychiatric Symptoms of Dementia']}, 'descriptionModule': {'briefSummary': 'This is a monocentric prospective, randomized, double-blind placebo-controlled study. It is designed to evaluate the superiority of the rTMS over sham treatment of depressive symptoms in the context of dementia. It is aimed at a population ≥ 65 years old, with affective BPSD. We wish to recruit 44 participants, with an estimated rate of potential drop out of 20%. Patients will be randomly assigned to the sham or rTMS group. The sham stimulation reproduces the procedure in all the steps, has the same duration and differs exclusively by the device setting. After inclusion, both groups will receive 15 sessions distributed over 5 days a week for 3 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent as documented by their and their proxy's signature (Appendix Informed Consent Form)\n* Consent for MRI\n* Age ≥ 65 years\n* Clinical dementia Rating Scale (CDR) ≥ 1\n* NPI-Q Σ (\\*Anxiety + \\* Apathy/Indifference + \\* Dysphoria/Depression) ≥ 3\n* Cornell Scale for Depression in Dementia (CSDD) ≥ 10\n\nExclusion Criteria:\n\n* History of schizophrenia, bipolar disorder, schizoaffective disorder\n* History of macroscopic stroke.\n* Unstable somatic pathologies\n* Insufficient collaboration for the rTMS procedure\n* Drug freeness or drug adjustment as clinically required is not an exclusion criterion.\n* The proxy refuses to give consent in case of lack of capacity, or in any case where the participant expresses a wish not to participate/continue in the study.\n* Any contraindications to performing an MRI (cf CRF) and rTMS (aneurysm clips or coils, stents in the neck or brain, deep brain stimulators, electrodes to monitor brain activity, metal implants in the ears and eyes, facial tattoos with metallic or magnetically sensitive ink) procedure"}, 'identificationModule': {'nctId': 'NCT05262868', 'acronym': 'rTMS-PSYGER', 'briefTitle': 'rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Affective Symptoms in Patients Suffering From Dementia: a Randomised Clinical Trial', 'orgStudyIdInfo': {'id': '2021-D0067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Magnetic stimulus intensity of 80% of the motor threshold applied at the frequency of 20 Hz over the left DLPFC with a total number of pulses of 1200 / treatment session for a total of 5 sessions /week for 3 consecutive weeks', 'interventionNames': ['Device: rTMS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham', 'description': 'Sham procedure implies the use of a "sham" coil of exactly the same dimension and appearance as the one used for the effective treatment. This sham coil is made for research purposes by the producing company and used in accordance with the instructions for use, which explicitly mention it (cf. instruction manual page 34: Stimulation Coil DuoMAG 70BFP (70BFP1, 70BFP2), typical use for blinded studies).', 'interventionNames': ['Device: rTMS']}], 'interventions': [{'name': 'rTMS', 'type': 'DEVICE', 'description': 'The stimulus intensity will be 80% of the motor threshold and the frequency will be 20 Hz for all patients. The total number of pulses will be 1200 for a single treatment session. We plan a total of 15 sessions distributed over 5 days a week for 3 consecutive weeks.', 'armGroupLabels': ['Active', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1008', 'city': 'Prilly', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Supaa - Chuv', 'geoPoint': {'lat': 46.53698, 'lon': 6.60456}}], 'overallOfficials': [{'name': 'Armin von Gunten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Prof Armin von Gunten', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}