Status:
COMPLETED
Low-Intensity Focused Ultrasound on Individuals With Disorder of Consciousness of Traumatic Brain Injury
Lead Sponsor:
Seoul National University Hospital
Conditions:
Traumatic Brain Injury With Prolonged Loss of Consciousness
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
Low-intensity focused ultrasound can be effective in severe TBI patients with disorder of consciousness. This study is a prospective single arm, open-label and explorative clinical trial to evaluate t...
Detailed Description
Traumatic brain injury (TBI) is an important global health concern. It is estimated that about 70 million individuals will suffer a traumatic brain injury (TBI) each year. Serious TBIs for hospitaliza...
Eligibility Criteria
Inclusion
- Age is 19 years or higher
- The patient was diagnosed with traumatic brain injury
- A patient 6 months after brain damage
- A patient was diagnosed with unwakefulness syndrome or minimally conscious state
Exclusion
- The patient needs changes of drugs that can affect changes in consciousness during the study's participation.
- The drugs listed below are not allowed to be used in combination, unless they are being taken stably from 4 weeks prior to screening.
- Benzodiazepines
- Anti-epileptic drugs
- Selective serotonin reuptake inhibitor
- Opioids
- Cardiopulmonary resuscitation was performed on the patient for more than 10 minutes
- The patients has uncontrolled seizure.
- The patient has severe thalamic atrophy of both sides, and it is impossible to determine the target area to be stimulated by sonication
- The patient has severe medical conditions which can affect the consciousness
- In brain computed tomography, calcification or foreign object (metallic materials, shunt catheter, etc.) that affects sonication are found in brain or skull.
- In brain MRI, an abnormal brain blood flow or blood vessel is found
- The patient is pregnant
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04306601
Start Date
June 25 2020
End Date
December 22 2022
Last Update
April 17 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744