Clinical Trial: EEG phase-locking phenomenon in blind people avoiding a collision with an energized signal (Japan)

Tokyo, July 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058450) titled 'EEG phase-locking phenomenon in blind people avoiding a collision with an energized signal' on July 14.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Gunma Paz University

Condition: Condition - Visual impairment, behavioral control disorder, risk of falls Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effectiveness of a novel low-frequency electrical stimulation input method with position-phase effect for conveying information of approaching objects/persons to blind individuals, assessing its impact on collision avoidance success rate and reaction time reduction. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Intervention name: Approach warning by low-frequency current signal using position phase effect Intervention details Two electrodes are applied to symmetrical electrode sites (C4, C5, C6, L4, L5 equivalent sites) on the neck and lumbar skin, two different low-frequency current stimulus waveforms or different energizing patterns with adjusted position phase are applied to the skin, and physiological and behavioral responses based on recognition of the energizing signals arePhysiological and behavioral responses based on the recognition of the electric current signals are measured. Intervention period 1 day (1 experimental day) Number of interventions Number of interventions: 1 time (up to 10 times per subject) Intervention frequency: 10 consecutive trials, 2-minute pause between each trial Intervention amount: - Current frequency: 20 to 100 Hz - Potential intensity: 5 mA or less - Stimulus duration: up to 30 seconds each trial Interventions/Control_2 - Intervention name: Conventional low-frequency energizing stimulation with a single electrode on the forearm Intervention description: Low-frequency energizing stimulation with a single electrode applied to the medial forearm (conventional method) Duration of intervention: 1 day (1 experimental day) Number of interventions: 1 time (maximum of 2 trials for each subject) Frequency of intervention: 2 minutes of pause between each trial Amount of intervention: - Electric current frequency: 20 to 100 Hz - Electric potential intensity: 5 mA or less - Stimulation duration: maximum 30 seconds for each trial

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Adults over 20 years old 2. who have read the instructions, understand the purpose of the research, and agree to participate in the research voluntarily 3. who do not have severe balance dysfunction, peripheral neuropathy, or neuropathy due to diabetes 4. who can attend Gunma Paz University or a research collaborating institution 5. who can commute to Gunma Paz University or one of the research collaborating institutions Key exclusion criteria - 1. a person who has an implanted medical device such as a pacemaker 2. a person who has severe peripheral neuropathy or balance dysfunction 3. a person who has serious complications due to diabetes 4. a person who is unable to understand the content of the explanatory document and has difficulty obtaining consent 5. any other person whom the principal investigator determines is inappropriate to participate in this study. Target Size - 14

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 05 Month 23 Day Date of IRB - 2024 Year 05 Month 23 Day Anticipated trial start date - 2024 Year 06 Month 01 Day Last follow-up date - 2026 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066833

Disclaimer: Curated by HT Syndication.