Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 3:14 PM
Study NCT ID:
NCT02793258
Status:
COMPLETED
Last Update Posted:
2022-01-27
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of tDCS on Emotional Processing in Major Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-26', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of correct responses at a facial expression recognition task', 'timeFrame': 'within 5 days after stimulation', 'description': 'A computerized facial expression recognition task was designed for the study. 240 pictures of emotional faces (8 identities, expressing anger, sadness, happiness, surprise, disgust, or fear, morphed with intensity of 20, 40, 50, 60 and 80%) are randomly displayed on a screen for 500ms. Subjects are asked to identify the emotion by answering on a keyboard.\n\nRate of correct responses is the main outcome. During this task, eye movements are recorded by an eye-tracking device. Skin conductance, respiratory and heart rate frequency are also recorded'}], 'secondaryOutcomes': [{'measure': 'Evolution of the depressive symptoms measured by MADRS', 'timeFrame': 'an average of two weeks', 'description': 'Montgomery-Asberg Depression Rating Scale is a 10-item scale to evaluate the intensity of the depressive symptoms.'}, {'measure': 'Performance on an attentional dot-probe task', 'timeFrame': 'within 5 days after stimulation', 'description': 'Computerized "dot-probe " attentional task designed for the study. Pairs of emotional faces (neutral/sad ou neutral/happy) are randomly presented on a screen for 1000ms. Then, a probe is presented during 1100ms.subjects are asked to indicate a which side the probe approved During this task, eye movements are recorded by an eye-tracking device. Total time spent on Region of Interest (sad, happy or neutral face) is measured.\n\nSkin conductance, respiratory and heart rate frequency are also recorded.'}, {'measure': 'tests of executive functions', 'timeFrame': 'an average of two weeks', 'description': 'Neuropsychological assessment : attentional functioning (TAP), executive functioning (BADS, working memory, go/no-go, stroop), memory (california verbal learning test) Improvement of executive functioning by tDCS will be assessed.'}, {'measure': 'Beck depression inventory scale', 'timeFrame': 'within 5 days after stimulation'}, {'measure': 'Clinical global impression scale', 'timeFrame': 'an average of two weeks'}, {'measure': 'Eye movements during facial emotion recognition task and attentional task', 'timeFrame': 'within 5 days after stimulation', 'description': 'Recorded by Eye tracker.Measurement of total time spent on specific Region of interest (eyes, nose, mouth, emotional face)'}, {'measure': 'Skin conductance measured in speed per microseconds', 'timeFrame': 'within 5 days after stimulation', 'description': 'Recorded with physiologic data system (BIOPAC)'}, {'measure': 'Heart rate measured in number of heart pulses per milliseconds', 'timeFrame': 'within 5 days after stimulation', 'description': 'Recorded with physiologic data system (BIOPAC)'}, {'measure': 'Respiratory frequency measured in number of respiratory cycles per minute', 'timeFrame': 'within 5 days after stimulation', 'description': 'Recorded with physiologic data system(BIOPAC)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tDCS', 'neuromodulation', 'depression', 'cognition'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ch-le-vinatier.fr/offre-de-soins/la-recherche/les-equipes/equipe-psr2-706.html', 'label': 'Equip (PSYR2) -Psychiatric Disorders: from Resistance to Response'}]}, 'descriptionModule': {'briefSummary': 'Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. In this randomized double-blind study, the investigators aim to assess the effect of tDCS on emotional processing in major depression.', 'detailedDescription': 'Methods: 40 subjects with major depression (20 active treatment and 20 placebo) will receive ten 30-minutes sessions of active two milliamps or sham tDCS (anode over left dorsolateral prefrontal cortex and cathode over right dorsolateral prefrontal cortex), twice a day for 5 consecutive days. Psychometric assessment of depression (MADRS,Beck Depression Inventory , CGI) and a neuropsychological assessment will be conducted before and after the treatment.\n\nA facial emotion recognition task and an attentional emotional task with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.\n\nThe investigators hypothesize that active tDCS will improve emotional processing in major depression, and that this will be observed after 1 and 10 sessions of tDCS.\n\nConclusions: Studying the impact of transcranial direct current stimulation on emotional processing in major depression could allow to better understand its antidepressant mechanisms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy controls:\n\n* Age between 18 and 65 years\n* Given consent.\n\nDepressed subjects:\n\n* Major depressive episode (no psychotic features) according to Diagnostic ans Statistical of Mental Disorders number 5 (DSM 5.0.)\n* Age from 18-65\n* Antidepressant stable for the last 4 weeks\n* MADRS ≥ 20.\n* Given consent\n\nExclusion Criteria:\n\nHealthy controls:\n\n* Psychiatric disorder\n* Addiction except for tobacco addiction\n* Ocular disease (except from refraction disorders), neurologic or cardiac disease.\n* Neuroleptic or anticonvulsivant treatment\n* Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)\n\nDepressed subjects:\n\n* Other psychiatric disorder except for personality disorders\n* Ocular disease (except from refraction disorders), neurologic or cardiac disease.\n* Neuroleptic or anticonvulsivant treatment\n* Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)'}, 'identificationModule': {'nctId': 'NCT02793258', 'acronym': 'EmoStim', 'briefTitle': 'Impact of tDCS on Emotional Processing in Major Depression', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital le Vinatier'}, 'officialTitle': 'Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression', 'orgStudyIdInfo': {'id': '2016-A00415-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo tDCS', 'description': 'Subjects will receive 10 30-minutes sessions of sham tDCS, twice a day for 5 consecutive day.\n\nFacial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.', 'interventionNames': ['Device: transcranial direct current stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Active tDCS', 'description': 'receive 10 30-minutes sessions of two milliamps tDCS, twice a day for 5 consecutive day.\n\nStimulation will be performed using an tDCS stimulator with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Anode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and cathode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system) The twice daily sessions will be separated by at least 2 hours.', 'interventionNames': ['Device: transcranial direct current stimulation']}], 'interventions': [{'name': 'transcranial direct current stimulation', 'type': 'DEVICE', 'description': 'Subjects will receive 10 30-minutes sessions of two milliamps transcranial direct current stimulation , twice a day for 5 consecutive day.\n\nFacial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.', 'armGroupLabels': ['Active tDCS', 'Placebo tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69678', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Ch Le Vinatier', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'HAESEBAERT FREDERIC, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier le Vinatier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital le Vinatier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}