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

NCT04306601 | Completed

• 1 other identifier: TBI_DoC_tFUS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury With Prolonged Loss of Consciousness

Outcome Measures

Primary Outcomes (3)

• Clinical evaluation

  Coma Recovery scale - Revised The CRS consists of 25 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, oromotor, communication, and arousal processes. Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors. The total minimum and maximum values are 0 and 23.

  6 weeks

• Quantitative electroencephalography

  Weighted phase lag index

  2 weeks

• Resting state functional MRI

  ALFF (amplitude of low-frequency fluctuation)

  2 weeks

Secondary Outcomes (4)

• Adverse reaction

  2 weeks

• Rancho Los Amigos Levels of Cognitive Functioning Scale (LOCF)

  6 weeks

• Glasgow Coma Scale

  6 weeks

• Glasgow Outcome Scale Extended

  6 weeks

Study Arms (1)

Low-Intensity focused ultrasound brain stimulation

EXPERIMENTAL

Low-intensity focused ultrasound brain stimulation using focused ultrasound system (NS-US100; NEUROSONA Co. Ltd., Seoul, Korea)

Device: Low-Intensity Focused Ultrasound

Interventions

Low-Intensity Focused Ultrasound DEVICE

Low-intensity focused ultrasound brain stimulation using focused ultrasound system (NS-US100; NEUROSONA Co. Ltd., Seoul, Korea)

Low-Intensity focused ultrasound brain stimulation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Officials

• Byung-Mo Oh, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Byung-Mo Oh, MD, PhD

Model Details: Patients with unwakefulness syndrome or minimally conscious state after traumatic brain injury

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 13, 2020
• Study Start: June 25, 2020
• Primary Completion: November 28, 2022
• Study Completion: December 22, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)