Tokyo, May 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061615) titled 'The Effect of Individual Variations in Current Direction Within the Primary Somatosensory Cortex on Tactile Function Induced by tDCS' on May 18.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Niigata University of Health and Welfare
Condition:
Condition - Central nervous system disorders
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In this study, we will use individual MRI scans and electric field simulations to evaluate the direction of the electric field vectors generated within each subject's S1 when tDCS is applied to S1 using a fixed electrode configuration. Furthermore, by clarifying the relationship between the direction of the current applied to S1 and changes in tactile function and somatosensory evoked potentials (SEP), we aim to elucidate the neurophysiological factors underlying individual differences in the effects of tDCS stimulation.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Transcranial Direct Current Stimulation
Stimulation duration: 20 minutes; stimulation intensity: 2 mA; fade-in/fade-out: 15 seconds each; electrode size: 5 x 5 cm
Conventional electrode placement conditions
Interventions/Control_2 - Transcranial Direct Current Stimulation
Stimulation duration: 20 minutes; stimulation intensity: 2 mA; fade-in/fade-out: 15 seconds each; electrode size: 5 x 5 cm
Current applied perpendicular to the gyri
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - The inclusion criteria were right-handed, healthy adults aged 18 to 30 who were eligible for MRI and tDCS, had received a thorough explanation of the study, and had provided written informed consent.
Key exclusion criteria - Exclusion criteria included individuals with a history of neurological or psychiatric disorders, those with sensory impairments or upper limb dysfunction, those with contraindications for MRI or tDCS, those taking medications that affect neural excitability, and those deemed unable to complete the study.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 18 Day
Anticipated trial start date - 2026 Year 05 Month 18 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070492
Disclaimer: Curated by HT Syndication.