Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT04343612
Status:
UNKNOWN
Last Update Posted:
2020-05-20
First Post:
2020-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Montages of Transcranial Direct Current Stimulation Tongue Strength
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'], 'maskingDescription': 'Everyone is blinded, codes are selected by a third party not involved in any step of the study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '4 groups, each group receives one of three treatments or the sham treatment. Double-blinded, sham controlled, crossover study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2020-04-10', 'lastUpdatePostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Tongue Maximal Strength', 'timeFrame': 'Baseline, immediately after, and 30 minutes after tDCS', 'description': '1 RM of tongue strength, measured using the IOPI device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tDCS', 'IOPI', 'Tongue Strength', 'Healthy'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '30431445', 'type': 'BACKGROUND', 'citation': 'Bornheim S, Croisier JL, Maquet P, Kaux JF. Proposal of a New Transcranial Direct Current Stimulation Safety Screening Tool. Am J Phys Med Rehabil. 2019 Jul;98(7):e77-e78. doi: 10.1097/PHM.0000000000001096. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '20 healthy subjects will be split into 4 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal or placebo Subjects will receive 2mA for 20 mins of their attributed tDCS. The evaluation is a maximal strength test measured with the IOPI and will take place prior to, immediately following and 30 minutes after stimulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n\nExclusion Criteria:\n\n* One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)'}, 'identificationModule': {'nctId': 'NCT04343612', 'briefTitle': 'Different Montages of Transcranial Direct Current Stimulation Tongue Strength', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'The Effects of Different Montages of Transcranial Direct Current Stimulation on Tongue Strength in Healthy Subjects', 'orgStudyIdInfo': {'id': '2020-93'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal', 'description': 'Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral', 'description': 'Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Cathodal', 'description': 'Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area. 2 mA, 20min stimulation', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'anode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'Subjects received a micro-current through their scalp to induce cortical and subcortical changes', 'armGroupLabels': ['Anodal', 'Bilateral', 'Cathodal', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Stephen Bornheim, Msc', 'role': 'CONTACT'}], 'facility': 'Liege Univeristy', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Stephen Bornheim, Msc', 'role': 'CONTACT', 'email': 'stephen.bornheim@uliege.be', 'phone': '003243662193'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Bornheim Stephen', 'investigatorAffiliation': 'University of Liege'}}}}