Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-20 @ 10:56 PM
Study NCT ID:
NCT04817566
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2021-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Working memory performance at post-assessment', 'timeFrame': '3 weeks', 'description': 'Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task'}], 'secondaryOutcomes': [{'measure': 'Working memory performance at follow-up assessment', 'timeFrame': '4 weeks after training', 'description': 'Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task'}, {'measure': 'Working memory training performance (Letter Updating Task) at post-assessment', 'timeFrame': '3 weeks', 'description': 'Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task'}, {'measure': 'Working memory training performance (Letter Updating Task) at follow-up assessment', 'timeFrame': '4 weeks after training', 'description': 'Performance in primary memory training task (Letter Updating Task) at follow-up assessment, operationalized by number of correctly recalled lists in the letter updating task'}, {'measure': 'Quality of Life at post-assessment', 'timeFrame': '3 weeks', 'description': 'PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)'}, {'measure': 'Quality of Life at follow-up assessment', 'timeFrame': '4 weeks after training', 'description': 'PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)'}, {'measure': 'Visuo-spatial performance at post-assessment', 'timeFrame': '3 weeks', 'description': 'Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.'}, {'measure': 'Visuo-spatial performance at follow-up assessment', 'timeFrame': '3 weeks', 'description': 'Visuo-spatial performance at follow-up assessment operationalized by number of correctly recalled items in the VR task.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '40398955', 'type': 'DERIVED', 'citation': 'Rocke M, Knochenhauer E, Thams F, Antonenko D, Fromm AE, Jansen N, Aziziaram S, Grittner U, Schmidt S, Vogelgesang A, Brakemeier EL, Floel A. Neuromodulation through brain stimulation-assisted cognitive training in patients with post-chemotherapy subjective cognitive impairment (Neuromod-PCSCI) after breast cancer: study protocol for a double-blinded randomised controlled trial. BMJ Open. 2025 May 21;15(5):e096162. doi: 10.1136/bmjopen-2024-096162.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether a high definition tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in women with post-chemotherapy cognitive impairment after breast cancer treatment.', 'detailedDescription': "Patients who have undergone chemotherapy, may develop post-chemotherapy cognitive impairment (PCCI), which may occur in several cognitive domains and persist for many years. These declines in cognitive functions can lead to psychological distress and affect overall patients' quality of life. The goal of the present study is to assess behavioral effects of a multi-session cognitive training combined with high-definition transcranial direct current stimulation (tDCS) in women with PCCI. First studies have shown positive effects of cognitive training on trained and untrained functions and the subjective perception of stress, however the effects are small and transfer effects are inconsistent. A promising approach to elongate and increase the effects of cognitive training is to combine the training with tDCS. Therefore, in this study women with PCCI will participate in a three-week cognitive training with concurrent online high-definition tDCS application. Cognitive performance (primary), as well as Quality of Life scores and Sleep data will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training intervention in women with PCCI in order to establish its potential to induce improvements in cognitive functions, and to beneficially affect patient-reported outcome measures."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chemotherapy to treat breast cancer (≥ 6 months post-treatment).\n2. Self-reported concerns regarding cognitive functioning.\n3. Age: 18-65 years.\n4. right-handedness\n\nExclusion Criteria:\n\n1. History of dementia before treatment of cancer.\n2. Other neurodegenerative neurological disorders; epilepsy or history of seizures.\n3. Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician.\n4. History of moderate to severe substance use disorder according to DSM-5\n5. Moderate to severe acute psychiatric disorders according to DSM-5\n6. Contraindication to tDCS application (Antal et al., 2017)'}, 'identificationModule': {'nctId': 'NCT04817566', 'acronym': 'NeuroMod-PCCI', 'briefTitle': 'Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-chemotherapy Cognitive Impairment', 'orgStudyIdInfo': {'id': 'NeuroMod-PCCI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stimulation group', 'description': 'Anodal tDCS+ intensive cognitive Training', 'interventionNames': ['Device: Anodal tDCS', 'Behavioral: Intensive cognitive training']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham group', 'description': 'Sham tDCS + intensive cognitive Training', 'interventionNames': ['Device: Sham tDCS', 'Behavioral: Intensive cognitive training']}], 'interventions': [{'name': 'Anodal tDCS', 'type': 'DEVICE', 'description': 'Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA).', 'armGroupLabels': ['stimulation group']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants.', 'armGroupLabels': ['sham group']}, {'name': 'Intensive cognitive training', 'type': 'BEHAVIORAL', 'description': 'Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min', 'armGroupLabels': ['sham group', 'stimulation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Greifswald', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Agnes Flöel, Prof.', 'role': 'CONTACT', 'email': 'agnes.floeel@med.uni-greifswald.de', 'phone': '0049 3834 86 6815'}], 'facility': 'University Medicine Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'centralContacts': [{'name': 'Agnes Flöel, Prof.', 'role': 'CONTACT', 'email': 'agnes.floeel@med.uni-greifswald.de', 'phone': '0049 3834 86 6815'}, {'name': 'Daria Antonenko, Dr.', 'role': 'CONTACT', 'email': 'daria.antonenko@med.uni-greifswald.de', 'phone': '0049 3834 86 6754'}], 'overallOfficials': [{'name': 'Agnes Flöel, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medicine Greifswald'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Greifswald', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}