Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 1:37 PM
Study NCT ID:
NCT03297450
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TDCS and Aphasia Therapy in the Acute Phase After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'aphasia therapy (45 minutes) in combination with (sham or real) tDCS (20 minutes)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Difficult patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2017-09-28', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in naming performance', 'timeFrame': 'baseline, 1 week, 3 months, 6 months', 'description': 'Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months'}, {'measure': 'Change in Vital Parameters', 'timeFrame': 'baseline, 1 hour (each session)', 'description': 'Blood pressure and heart rate will be measured before and after each session of treatment'}], 'secondaryOutcomes': [{'measure': 'Change in tolerability (Visual analogue scale)', 'timeFrame': 'baseline, 1 hour (each session)', 'description': 'A Visual analogue scale will assess tolerability before and immediately after each session'}, {'measure': 'Change in Spontaneous Speech', 'timeFrame': 'baseline, 1 week, 3 months, 6 months', 'description': 'A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 and 6 months'}, {'measure': 'Change in ERPs', 'timeFrame': 'baseline, 1 week, 3 months, 6 months', 'description': 'Evoked potentials will be measured at baseline, immediately after treatment and after 3 and 6 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aphasia Following Cerebral Infarction']}, 'descriptionModule': {'briefSummary': 'This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the acute stage after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.', 'detailedDescription': 'Aphasia is present in about one third of all stroke patients in the acute phase. The first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. Language recovery in aphasic stroke patients involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. Left re-lateralization, if possible, seems to be the most effective in restoring language function. For a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such as transcranial direct current stimulation (tDCS) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA) between two electrodes. These weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. The effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. It was suggested that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with mild-moderate aphasia (Token Test Score between 7 and 40)\n* Inclusion in the first few days after stroke (acute phase)\n* Age 18 - 85 years\n* Being right-handed\n* Mothertongue: Dutch\n* Able to undergo functional and specific linguistic testing and therapy in the acute phase following stroke\n* Imaging (CT or MRI) prior to inclusion (standard of care)\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* History of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders\n* Serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in anamneses)\n* Prior brain surgery\n* Excessive use of alcohol or drugs"}, 'identificationModule': {'nctId': 'NCT03297450', 'briefTitle': 'TDCS and Aphasia Therapy in the Acute Phase After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation (tDCS) with Aphasia Therapy in the Acute Phase After Ischemic Stroke', 'orgStudyIdInfo': {'id': 'EC2017/0906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aphasia therapy and tDCS', 'interventionNames': ['Device: tDCS', 'Behavioral: Aphasia therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Aphasia therapy and sham-tDCS', 'interventionNames': ['Behavioral: Aphasia therapy', 'Device: Sham-tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Standard of care and sham-tDCS', 'interventionNames': ['Device: Sham-tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'description': 'C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA', 'armGroupLabels': ['Aphasia therapy and tDCS']}, {'name': 'Aphasia therapy', 'type': 'BEHAVIORAL', 'description': 'Based on linguistic tests, individualized aphasia therapy will be provided', 'armGroupLabels': ['Aphasia therapy and sham-tDCS', 'Aphasia therapy and tDCS']}, {'name': 'Sham-tDCS', 'type': 'DEVICE', 'description': 'tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)', 'armGroupLabels': ['Aphasia therapy and sham-tDCS', 'Standard of care and sham-tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East-Flanders', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Veerle De Herdt, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}