Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059695) titled 'Exploring a New Non-invasive Treatment for Motion Sickness Using Electrical Nerve Stimulation' on Nov. 10.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - St. Marianna University School of Medicine

Condition: Condition - Motion Sickness Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This pilot study aims to investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) in patients with motion sickness, assessed by subjective (MSAQ) and objective (VST) parameters. The study seeks to elucidate the therapeutic potential of TENS and to contribute to the establishment of a novel, non-invasive treatment modality for motion sickness. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Under the TENS-off condition, rotational stimulation at 60 degrees/sec will be applied for one minute, followed by one minute of post-rotatory nystagmus recording. The intervention will be conducted only once, and the total duration including post-measurement questionnaire completion will be approximately 10 minutes. Interventions/Control_2 - Under the TENS-on condition, rotational stimulation at 60 degrees/sec will be applied for one minute, followed by one minute of post-rotatory nystagmus recording. The intervention will be conducted only once, and the total duration including post-measurement questionnaire completion will be approximately 10 minutes.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Healthy adult men and women aged 18 years or older who have provided informed consent and do not meet any of the exclusion criteria. Key exclusion criteria - Individuals with a history of vestibular dysfunction Individuals using a pacemaker Individuals with a history of severe motion sickness Individuals with skin conditions that make transcutaneous electrical nerve stimulation (TENS) difficult to apply Pregnant individuals Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 05 Day Date of IRB - 2025 Year 11 Month 05 Day Anticipated trial start date - 2025 Year 11 Month 11 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068273

Disclaimer: Curated by HT Syndication.