NCT04877184

Feasibility Study of Transcranial Ultrasound Stimulation (TUS) on Stroke Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cheng-Hsin General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Currently, the main treatment method for Intracerebral Hemorrhage (ICH) is medication or surgery. However, the effectiveness of medicines is moderate and there are several side effects. In this clinical trial, we would like to enhance the protein levels of brain derived neurotrophic factor in the brain by the transcranial ultrasound stimulation (TUS). By this technology, the symptoms of ICH could be alleviated and the side effects of medicines might be avoided. Preclinical trials have also shown that low-intensity pulsed ultrasound can alleviate the degree of neuroinflammation, neurodegeneration and significantly improve motor and cognitive deficits after brain injury. The purpose of this clinical trial is to evaluate the safety and feasibility of TUS for the treatment of patients with hypertensive intracerebral hemorrhage. The primary safety assessment indexes are brain magnetic resonance imaging (MRI) and brain magnetic resonance angiography (MRA). The secondary safety assessment indexes include weight, vital signs, electrocardiogram, general blood biochemical tests, adverse reaction events, and concurrent drug tracking. The feasibility assessment includes blood specific biomarker expression and neurological function \& quality of life scales.

Conditions

• Intracerebral Hemorrhage
• Hemiplegia

Interventions

Type	Name	Description
DEVICE	Transcranial ultrasound stimulation and rehabilitation	The participants in experimental group would received transcranial ultrasound stimulation and rehabilitation therapy. * transcranial ultrasound stimulation: during 4 weeks * rehabilitation: physiotherapy and occupational therapy (may combine with speech therapy and psychological therapy if needed)
DEVICE	Rehabilitation	The participants in control group would received rehabilitation therapy. \- rehabilitation: physiotherapy and occupational therapy (may combine with speech therapy and psychological therapy if needed)

Timeline

• Start date: 2021-07-08
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-05-07
• Last updated: 2023-03-07

Locations

1 site across 1 country: Taiwan