Tokyo, Sept. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062995) titled 'A study of galvanic vestibular stimulation for impaired awareness of hemiplegia after stroke' on Sept. 20.

Study Type: Interventional

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

Primary Sponsor: Institute - Kansai Electric Power Hospital

Condition: Condition - Anosognosia for hemiplegia following ischemic or hemorrhagic stroke Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to explore the effects of adding galvanic vestibular stimulation to usual rehabilitation on the severity of anosognosia for hemiplegia in patients with ischemic or hemorrhagic stroke. The secondary objectives are to evaluate changes in unilateral spatial neglect, motor function, activities of daily living, and cognitive function, as well as the persistence of the intervention effects and the feasibility of galvanic vestibular stimulation. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - A single-arm intervention with an A-B-A-prime phase structure in which galvanic vestibular stimulation is added to usual rehabilitation. The study period is 6 weeks. During the A phase (weeks 1-2), participants receive usual rehabilitation alone, including lower-extremity muscle strengthening, balance training, and gait training. During the B phase (weeks 3-4), galvanic vestibular stimulation is added to usual rehabilitation using the Intelect Advance Combo combination electrotherapy system (Chattanooga; medical device certification number: 220AIBZX00049000). Participants receive stimulation in a seated position with 3 x 3 cm electrodes placed over the bilateral mastoid processes. Stimulation is delivered for 15 minutes once daily on weekdays, 5 days per week for 2 weeks, for a total of 10 sessions. The stimulation intensity is individually adjusted within a tolerable, non-discomfort range based on the sensory threshold measured before the intervention and participant tolerability; the target intensity is approximately 1.5 mA. During the A-prime phase (weeks 5-6), participants receive usual rehabilitation alone again.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients admitted to the Convalescent Rehabilitation Ward of Kansai Electric Power Hospital 2.Patients diagnosed with ischemic or hemorrhagic stroke who present with hemiplegia 3.Patients judged to have anosognosia for hemiplegia based on an anosognosia assessment 4.Patients presenting with at least one of the following: unilateral spatial neglect or pusher syndrome 5.Patients for whom written informed consent to participate in the study is obtained from the participant or an appropriate legally authorized representative Key exclusion criteria - 1.Patients judged to have difficulty understanding the study procedures or cooperating with the study assessments because of severe dementia, aphasia, disorders of consciousness, or other conditions 2.Patients with implanted medical devices or metal materials that may interfere with study participation, such as a pacemaker, cochlear implant, or aneurysm clip, in the intracranial or cervical region 3.Patients with a history of epileptic seizures 4.Patients with skin disease or wounds at the mastoid processes, which are the stimulation sites 5.Patients whom the attending physician or principal investigator judges to be inappropriate for participation in the study for any other reason Target Size - 8

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 10 Day Date of IRB - 2026 Year 09 Month 10 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2028 Year 08 Month 11 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072116

Disclaimer: Curated by HT Syndication.