| 제목 |
Effectiveness and safety of low-intensity tFUS on patients with post-traumatic DOC: Study protocol |
| 소속 |
Seoul National University Hospital, Department of Rehabilitation Medicine1, Dong-A University Hospital, Department of Physical Medicine and Rehabilitation2, Seoul National University Hospital , Department of Radiology3, Seoul National University College of Medicine, Neuroscience Research Institute4, Seoul National University Hospital, Department of Neurology5, Seoul National University College of Medicine, Department of Neurology6, Brigham and Women`s Hospital, Harvard Medical School, Department of Radiology7, Seoul National University Hospital, Division of bioStatistics8, National Traffic Injury Rehabilitation Hospital, Department of Rehabilitation Medicine9 |
| 저자 |
Min-Yong Lee1*, Min Yong Seong1, Min-Gu Kang1,2, Hee Jae Kim1, Seo Jung Yun1, Eunkyung Kim1, Inpyeong Hwang3, Roh-Eul Yoo3, Kwang Su Cha4, Ki-Young Jung5,6, Wonhye Lee7, Seung-Schik Yoo7, Yunhee Choi8, Aram Kim1, Han Gil Seo1, Byung-Mo Oh1,9† |
Background: Post-traumatic disorders of consciousness (DOC) make patients lose autonomy, placing a burden on their families. Currently, there are no effective treatments for patients with post-traumatic DOC. Low-intensity transcranial focused ultrasound (tFUS) has been newly proposed as a non-invasive neuromodulatory technique, with exquisite spatial selectivity and ability to reach deep brain areas. This study aims to explore the therapeutic effectiveness and safety of tFUS stimulation to the thalamus in patients with post-traumatic DOC, who were ≥ 6 months after TBI.
Methods: This study will be a prospective, open-label, single-arm, single-center and explorative clinical trial. Ten patients with post-traumatic DOC will be recruited, and the intervention period will be 14 days. Guided by individual-specific neuroimage data, tFUS stimulation will be delivered to central thalamus targeting the central lateral group of intralaminar nuclei of the unilateral thalamus. Patients will receive six 30-min sessions of stimulation during the intervention period. The primary outcome measures will be changes in coma recovery scale-revised. The secondary outcome measures include other clinical evaluations (Rancho Los Amigos scale, Glasgow coma scale, and Glasgow outcome scale-extended) and the functional connectivity of the whole brain area, using resting state functional magnetic resonance image and quantitative electroencephalogram data. All adverse events will be included in the safety assessment. Because tFUS stimulation will be conducted in the injured brain, physicians will monitor patients carefully for seizure event during the study period. To identify subclinical seizures, electroencephalography will be performed twice in the intervention period. The patient’s skin will be checked for skin damage before and after tFUS stimulation.
Discussion: This study will be the prospective open label clinical trial examining the use of tFUS stimulation in patients with post-traumatic DOC. The results of this study will demonstrate the potential of tFUS as a new treatment technique of DOC. |
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Fig 1. NS-US100, a tFUS stimulation system.
Fig 2. An example of the image-guidance for the tFUS stimulation. The green crosslines shown in axial, sagittal, and coronal views indicate the stimulation target, and the thick green line and yellow line represent the sonication path and planned path, respectively.
Table 1. Study schedule of enrollment, intervention and assessments.
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