Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
Study NCT ID:
NCT04577768
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Transcranial Direct Current Stimulation on Motor Performance in Healthy Adults
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']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial (RCT)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in movement time (s) from baseline to intervention', 'timeFrame': 'Baseline (immediately before stimulation), two minutes after starting the stimulation', 'description': 'Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.'}, {'measure': 'Change in movement time (s) from baseline to posttest', 'timeFrame': 'Baseline (immediately before stimulation), immediately post stimulation', 'description': 'Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.'}, {'measure': 'Change in movement time (s) from baseline to retention test', 'timeFrame': 'Baseline (immediately before stimulation), 24 hours following the stimulation', 'description': 'Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.'}, {'measure': 'Change in movement time (s) from intervention to posttest', 'timeFrame': 'Two minutes after starting the stimulation, immediately post stimulation', 'description': 'Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.'}, {'measure': 'Change in movement time (s) from intervention to retention test', 'timeFrame': 'Two minutes after starting the stimulation, 24 hours following the stimulation', 'description': 'Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.'}, {'measure': 'Change in movement time (s) from posttest to retention test', 'timeFrame': 'immediately post stimulation, 24 hours following the stimulation', 'description': 'Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.'}, {'measure': 'Change in reaction time (s) from baseline to intervention', 'timeFrame': 'Baseline (immediately before stimulation), two minutes after starting the stimulation', 'description': 'Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.'}, {'measure': 'Change in reaction time (s) from baseline to posttest', 'timeFrame': 'Baseline (immediately before stimulation), immediately post stimulation', 'description': 'Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.'}, {'measure': 'Change in reaction time (s) from baseline to retention test', 'timeFrame': 'Baseline (immediately before stimulation), 24 hours following the stimulation', 'description': 'Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.'}, {'measure': 'Change in reaction time (s) from intervention to posttest', 'timeFrame': 'Two minutes after starting the stimulation, immediately post stimulation', 'description': 'Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.'}, {'measure': 'Change in reaction time (s) from intervention to retention test', 'timeFrame': 'Two minutes after starting the stimulation, 24 hours following the stimulation', 'description': 'Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.'}, {'measure': 'Change in reaction time (s) from posttest to retention test', 'timeFrame': 'immediately post stimulation, 24 hours following the stimulation', 'description': 'Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcranial direct current stimulation', 'motor performance'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '34174914', 'type': 'DERIVED', 'citation': 'Lerner O, Friedman J, Frenkel-Toledo S. The effect of high-definition transcranial direct current stimulation intensity on motor performance in healthy adults: a randomized controlled trial. J Neuroeng Rehabil. 2021 Jun 26;18(1):103. doi: 10.1186/s12984-021-00899-z.'}]}, 'descriptionModule': {'briefSummary': 'to investigate the effect of stimulation intensity on motor performance in healthy adults.', 'detailedDescription': '60 healthy subjects were randomly allocated to one of three groups: (a) 20-min of High-Definition transcranial direct current stimulation (HD-tDCS) with an intensity of 2 mA (HD-tDCS 2 mA); (2) 20-min of HD-tDCS with an intensity of 1.5 mA (HD-tDCS 1.5 mA); and (3) 20-min of sham HD-tDCS (HD-tDCS sham). The stimulation was administered noninvasively using an M x N 9-channel high definition transcranial electrical current stimulator from Soterix Medical (New York, NY). The anodal stimulation targeted the right Brodmann area 4 (primary motor cortex) based on HD-Targets brain modelling software (Soterix Medical, New York, NY).\n\nTests: The non-dominant left arm was tested. The subjects performed a sequential point-to-point movement task on the graphics tablet. Initially, the participants were required to perform 3 sequences without errors to familiarize themselves with the setup, the task and the sequence. Then, they performed the pre-test which consisted of two blocks of 6 sequences, i.e. 12 sequences, with a 30 s break between blocks. Two min after starting the appropriate stimulation, they performed 2 blocks of 6 sequences (identical to the pre-test). After finishing the tDCS stimulation, the participants performed a post-test, which was also identical to the pre-test. The participants returned after 24 hours to perform a retention test, which was equivalent to the pre- and post-tests. Two outcome measures were used: movement time (s) and the reaction time (s) of the reaching movements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 20 and 35\n* right-hand dominant\n* healthy according to self report\n\nExclusion Criteria:\n\n* taking psychiatric medications\n* a history of drug abuse or dependence\n* psychiatric or neurological disorder\n* a history of seizures\n* metal implants in their head\n* musculoskeletal deficits interfering with task performance (proper reaching performance in sitting)'}, 'identificationModule': {'nctId': 'NCT04577768', 'briefTitle': 'The Effect of Transcranial Direct Current Stimulation on Motor Performance in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Ariel University'}, 'officialTitle': 'The Effect of Transcranial Direct Current Stimulation Intensity on Motor Performance in Healthy Adults', 'orgStudyIdInfo': {'id': 'AU-HEA-SFT-20190326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HD-tDCS 2 mA', 'description': 'Single session of 20-min HD-tDCS to the right primary motor cortex with an intensity of 2 mA. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test.', 'interventionNames': ['Device: HD-tDCS 2 mA']}, {'type': 'EXPERIMENTAL', 'label': 'HD-tDCS 1.5 mA', 'description': 'Single session of 20-min HD-tDCS to the right primary motor cortex with an intensity of 1.5 mA. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test.', 'interventionNames': ['Device: HD-tDCS 1.5 mA']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Single session of 20-min of sham HD-tDCS. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test.', 'interventionNames': ['Device: HD-tDCS sham']}], 'interventions': [{'name': 'HD-tDCS 2 mA', 'type': 'DEVICE', 'description': 'anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 2 mA', 'armGroupLabels': ['HD-tDCS 2 mA']}, {'name': 'HD-tDCS 1.5 mA', 'type': 'DEVICE', 'description': 'anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1.5 mA', 'armGroupLabels': ['HD-tDCS 1.5 mA']}, {'name': 'HD-tDCS sham', 'type': 'DEVICE', 'description': 'sham stimulation of the right primary motor cortex', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ariel', 'country': 'Israel', 'facility': 'Ariel University', 'geoPoint': {'lat': 32.1065, 'lon': 35.18449}}], 'overallOfficials': [{'name': 'Silvi Frenkel-Toledo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ariel University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code generated during and/or analyzed during the current study) are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ariel University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tel Aviv University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}