Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063257) titled 'Cervical Muscle Stiffness and Clinical Outcomes in Patients with Spontaneous Intracranial Hypotension: An Exploratory Comparative Study' on Oct. 14.

Study Type: Observational

Primary Sponsor: Institute - Saitama Medical University

Condition: Condition - Spontaneous intracranial hypotension Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to measure cervical muscle stiffness in patients with spontaneous intracranial hypotension (SIH) and compare it with that of healthy controls. In addition, changes in cervical muscle stiffness before and after epidural blood patch treatment will be evaluated, and their associations with clinical outcomes, including pain intensity, quality of life (QOL), and psychological factors, will be explored. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Individuals diagnosed with spontaneous intracranial hypotension (SIH) according to the ICHD-3. Specifically, participants must present with persistent orthostatic headache and associated symptoms such as neck pain, dizziness, visual disturbances, and fatigue, with evidence of cerebrospinal fluid leakage on MRI and/or radionuclide cisternography.

Aged 18 years or older at enrollment.

Able to provide written informed consent. Key exclusion criteria - Individuals with neuromuscular disorders or cervical spine diseases that may affect cervical muscle stiffness. Individuals who are pregnant or breastfeeding. Individuals for whom the date of symptom onset, medical history, or medication history is unavailable or cannot be adequately ascertained. Individuals who lack the capacity to provide informed consent due to severe psychiatric disorders, dementia, or other conditions. Individuals who request exclusion from participation in this study. Individuals deemed unsuitable for participation by the principal investigator for any other reason. Target Size - 40

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 09 Month 01 Day Date of IRB - 2026 Year 10 Month 07 Day Anticipated trial start date - 2026 Year 10 Month 21 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070819

Disclaimer: Curated by HT Syndication.