Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT05959551
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2023-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HD-tDCS to Modulate Connectivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Randomization will happen after baseline assessment. After-intervention assessment will only consist of self-report and computerized assessment. Participants will not aware of the treatment group that they were assigned to.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '4 active treatment groups + 1 inactive treatment group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of functional connectivity', 'timeFrame': '0-11 minutes after the stimulation contrasting baseline (before stimulation)', 'description': 'Changes in seed-based connectivity originating from the targeted brain regions immediately after the brain stimulation'}], 'secondaryOutcomes': [{'measure': 'change of cerebral blood flow', 'timeFrame': '12-16 minutes after the stimulation contrasting baseline (before stimulation)', 'description': 'Changes in Cerebral Blood Flow (estimated using pseudo continuous arterial spin labeling )'}, {'measure': 'Toronto Mindfulness Scale (curiosity)', 'timeFrame': 'Baseline, then within 1-2 hours from stimulation', 'description': 'mindfulness scale for curiosity. min: 0, max: 30. Higher score means higher curiosity-mindfulness.'}, {'measure': 'Toronto Mindfulness Scale (decentering)', 'timeFrame': 'Baseline, then within 1-2 hours from stimulation', 'description': 'mindfulness scale for decentering. min: 0, max: 35. Higher score means higher decentering-mindfulness.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electricity; Effects']}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed study is to broaden our understanding on the neural effects of High Definition Transcranial Direct Current Stimulation (HD-tDCS) so that its clinical effects can be further improved.', 'detailedDescription': 'Normal healthy individuals will be recruited and undergo a standardized neuropsychological assessment (ANAM, MoCA, BDI-II, ToMS, and MAAS) and magnetic resonance imaging (MRI). During MRI, HD-tDCS will be applied. Four different stimulation targets will be investigated, and subjects will be randomly assigned for each target groups or sham group. After HD-tDCS/MRI session, subjects will be re-assessed with standardized neuropsychological tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All other than excluded.\n\nExclusion Criteria:\n\n* History or susceptibility to any neurological or psychiatric diseases, particularly seizures\n* abnormal MRI\n* metal implants or a cardiac pacemaker\n* pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT05959551', 'briefTitle': 'HD-tDCS to Modulate Connectivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Modulating Functional Brain Connectivity Using High Definition Transcranial Direct Current Stimulation (HD-tDCS)', 'orgStudyIdInfo': {'id': 'HS24853'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'left DLPFC stimulation', 'description': 'HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left dorsolateral prefrontal cortex (DLPFC; x=-44, y=10, z=30) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.', 'interventionNames': ['Device: high definition transcranial direct current stimulation (HD-tDCS)']}, {'type': 'EXPERIMENTAL', 'label': 'right DLPFC stimulation', 'description': 'HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the right dorsolateral prefrontal cortex (DLPFC; x=+42, y=+14, z=+30) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.', 'interventionNames': ['Device: high definition transcranial direct current stimulation (HD-tDCS)']}, {'type': 'EXPERIMENTAL', 'label': 'left IPL stimulation', 'description': 'HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left intraparietal lobe (IPL; x=-50, y=-36, z=+42) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.', 'interventionNames': ['Device: high definition transcranial direct current stimulation (HD-tDCS)']}, {'type': 'EXPERIMENTAL', 'label': 'VLPFC-PCC stimulation', 'description': 'HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left ventrolateral prefrontal cortex (VLPFC; x=-50, y=+26, z=+8) and posterior cingulate cortex (PCC; x=1, y=-61, z=38) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.', 'interventionNames': ['Device: high definition transcranial direct current stimulation (HD-tDCS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'description': 'One of the above three targets will be randomly selected. The current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down.', 'interventionNames': ['Device: high definition transcranial direct current stimulation (HD-tDCS)']}], 'interventions': [{'name': 'high definition transcranial direct current stimulation (HD-tDCS)', 'type': 'DEVICE', 'description': 'HD-tDCS will be provided for 20 minutes for each stimulation with peak intensity of 2mA.', 'armGroupLabels': ['Sham stimulation', 'VLPFC-PCC stimulation', 'left DLPFC stimulation', 'left IPL stimulation', 'right DLPFC stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3E 0J9', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ji Hyun Ko, PhD', 'role': 'CONTACT', 'email': 'ji.ko@umanitoba.ca', 'phone': '204-318-2566'}], 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Ji Hyun Ko, PhD', 'role': 'CONTACT', 'email': 'ji.ko@umanitoba.ca', 'phone': '2042930724'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Natural Sciences and Engineering Research Council, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}