Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061422) titled 'Effects of Multisensory Stimulation on Consciousness in Patients with Acute Stroke' on May 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Nagasaki University Hospital

Condition: Condition - Stroke Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study is a randomized controlled trial that aims to evaluate the efficacy of multisensory stimulation in patients with acute stroke who have disorders of consciousness (DOC). Participants will be randomly allocated to a rehabilitation group or a rehabilitation with multisensory stimulation group., and changes in the Coma Recovery Scale-Revised (CRS-R) score will be compared between the two groups as the primary outcome. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In addition to standard rehabilitation, multisensory stimulation (visual, auditory, olfactory, gustatory, tactile, kinesthetic, proprioceptive, and somatosensory) will be administered for 15 minutes per session. On the day informed consent is obtained, the intervention will be conducted in the afternoon; from the following day onward, it will be provided twice daily (morning and afternoon), five days per week. Interventions/Control_2 - Standard rehabilitation will be administered.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients admitted to the Stroke Center of Nagasaki University Hospital between the date of institutional approval and March 31, 2028. 2.Patients who meet a Glasgow Coma Scale (GCS) score of 3 to 12 as assessed by a physician at admission. 3.Patients with supratentorial cerebral infarction. 4.Patients aged 18 years or older who have received a full explanation of the study and for whom written informed consent has been obtained from a legally authorized representative based on their free will and sufficient understanding. Key exclusion criteria - 1.Patients with pre-existing disorders of consciousness (DOC) prior to admission. 2.Patients with an implanted cardiac device, such as a pacemaker. 3.Patients with hemodynamic instability. 4.Patients with a history of stroke or other neurological diseases. 5.Exclude individuals with a known allergy to citrus essential oils, those with a history of dermatitis or respiratory symptoms induced by essential oil use, and those with severe bronchial asthma. 6.Rehabilitation therapy exceeding 5 units per day during the multisensory stimulation intervention period. 7.Patients deemed inappropriate for participation in the study by the principal investigator. Target Size - 96

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 19 Day Anticipated trial start date - 2028 Year 05 Month 01 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=R000069454

Disclaimer: Curated by HT Syndication.