Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02945592
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2016-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Cue-Training in Neglect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010468', 'term': 'Perceptual Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in word and word-part omissions in standardized reading of text and word list', 'timeFrame': 'Primary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8', 'description': 'the patient has to read a standardized text of 55 words and a word list of 13 words. Omissions of the complete word and/or of a word part are counted.'}], 'secondaryOutcomes': [{'measure': 'Change in standardized evaluation of the body posture', 'timeFrame': 'Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8', 'description': 'A blinded neurologist evaluates spontaneous and cued body posture (head, eyes, trunk) for ipsilesional, moderate ipsilesional or no deviation.'}, {'measure': 'Change in Apples Cancellation Task', 'timeFrame': 'Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8', 'description': 'a standardized measurement for the evaluation of egocentric and allocentric neglect symptoms'}, {'measure': 'Change in activities of daily living using the Catherine Bergego Scale', 'timeFrame': 'Secondary Outcome Measure is assessed after week 1, after week 4, after week 7, after week 8', 'description': 'The blinded hospital staff evaluates activities of daily living by using the Catherine Bergego scale with specified scoring criteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemispatial Neglect', 'cueing', 'egocentric-allocentric', 'early rehabilitation', 'parietal tDCS'], 'conditions': ['Hemispatial Neglect']}, 'descriptionModule': {'briefSummary': 'The presented study investigates standardized visual cueing in reading and visual spatial task as a treatment method for spatial neglect. In a randomized controlled design patients receive either cued reading and visual spatial tasks (intervention) or treatment which is unspecific to neglect (control).\n\nIn the intervention condition, patients with left-sided neglect receive intense training, including reading and visual spatial task with standardized and adapted visual cueing by the therapist. Improvements in reading and visual spatial tasks lead to a reduction of cues by the therapist. Accordingly, the patient has to apply self-cueing over time in order to solve the task.\n\nFor the control condition, all patients receive unspecific treatment without any standardized adapted cueing implemented by the therapist.\n\nTo enhance the effectivity of cueing in reading and visual spatial tasks, the investigators additionally conduct parietal transcranial direct current stimulation (tDCS) in those patients without tDCS exclusion criteria (see exclusion criteria below).\n\nIt is hypothesised that systematic and adaptive therapeutic cueing leads to a significant reduction of omissions of word and word parts in reading.\n\nUPDATE: No Add-on tDCS was performed since it was not applicable for our severly impaired patients due to the strict exclusion criteria of tDCS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Left sided neglect\n* Capacity of at least 30 minutes\n* Ability to read in German language\n* Mobilization of 80%\n\nExclusion Criteria:\n\n* Previous known dementia\n* Normal pressure hydrocephalus\n\nExclusion Criteria for tDCS Add-on (not exclusion of the intervention):\n\n* Shunt\n* Craniectomy\n* Epilepsy\n* Other metal implants'}, 'identificationModule': {'nctId': 'NCT02945592', 'briefTitle': 'Active Cue-Training in Neglect', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum Bremen Ost'}, 'officialTitle': 'Active Cue-Training in Neglect', 'orgStudyIdInfo': {'id': '367915'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '* adaptive, therapeutic cueing during reading tasks\n* adaptive, therapeutic cueing during visuo spatial tasks', 'interventionNames': ['Behavioral: Cueing']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '\\- unspecific neglect treatment'}], 'interventions': [{'name': 'Cueing', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28325', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum Bremen-Ost', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}], 'overallOfficials': [{'name': 'Helmut Hildebrandt, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universität Oldenburg, Klinikum Bremen-Ost'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum Bremen Ost', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Nergiz Turgut', 'investigatorAffiliation': 'Klinikum Bremen Ost'}}}}