Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062078) titled 'Exploratory Study of Physiological Responses to Transvertebral Magnetic Stimulation' on July 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Okayama University Hospital

Condition: Condition - Healthy adults and patients with neurological disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to exploratorily evaluate physiological responses, including motor, sensory, and autonomic responses, induced by transvertebral magnetic stimulation in healthy adults and patients with neurological disorders, and to investigate the relationship between stimulation parameters, such as stimulation site, intensity, direction, and frequency, and the elicited biological responses. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Transvertebral magnetic stimulation will be performed as the main intervention, with transcutaneous electrical stimulation added when necessary. The participation period for each participant will be up to 30 weeks from the date of informed consent to the final assessment. Experimental sessions involving stimulation will be conducted up to 24 times per participant, generally no more than once per week. Each experimental session will last up to approximately 3 hours, including preparation, rest, and assessments before and after stimulation. In each session, transvertebral magnetic stimulation will be performed at rest and/or during voluntary motor tasks, and stimulation parameters such as intensity, frequency, stimulation site, and stimulation direction will be set exploratorily within a range that ensures participant safety. Transcutaneous electrical stimulation may be combined when necessary, and assessments such as electromyography, motion analysis, muscle strength assessment, sensory assessment, autonomic nervous system assessment, and transcranial magnetic stimulation-based evaluation will be performed.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Participants who meet all of the following criteria will be included:

Individuals who have received a sufficient explanation of the study and have provided written informed consent Individuals judged by the principal investigator or sub-investigator to be able to participate in the study Individuals who can understand the study tasks and follow instructions to perform motor tasks Individuals aged 18 years or older and younger than 90 years at the time of informed consent For healthy participants, individuals with no apparent history of neurological or muscular disease and no difficulty in voluntary movement of the upper or lower limbs For patients with neurological disorders, individuals with a history of neurological disorder, motor impairment of the upper or lower limbs, and a stable condition after the acute phase Key exclusion criteria - Individuals who meet any of the following criteria will be excluded:

1.Individuals whose underlying disease is unstable 2.Women who are pregnant or may be pregnant 3.Women who are breastfeeding 4.Individuals who have experienced adverse effects caused by magnetic or electrical stimulation 5.Individuals with implanted medical devices such as a cardiac pacemaker, deep brain stimulator, or insulin pump 6.Individuals judged by the principal investigator or sub-investigator to be unsuitable for participation in the study for any other reason Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 28 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2032 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070983

Disclaimer: Curated by HT Syndication.