CompletedNot Applicable

Low-Intensity Focused Ultrasound on Individuals With Disorder of Consciousness of Traumatic Brain Injury

South Korea10 participantsStarted 2020-06-25

Plain-language 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 the therapeutic effect of recovery from DoC and safety of low-intensity focused ultrasound stimulation at thalamic area in patients with post-traumatic DoC.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. The patient needs changes of drugs that can affect changes in consciousness during the study's participation.
✕. 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

What they're measuring

Clinical evaluation

Timeframe: 6 weeks

Quantitative electroencephalography

Timeframe: 2 weeks

Resting state functional MRI

Timeframe: 2 weeks

Trial details

NCT IDNCT04306601

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-28

View on ClinicalTrials.gov More Traumatic Brain Injury With Prolonged Loss of Consciousness trials