Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders

Based on the central loop hypothesis, deep brain stimulation (DBS) represents a commonly utilized neuro-modulation stimulation technology for disorders of consciousness (DOC). It was initially employed in Europe in 1968 for treating DOC. Some patients can regain functional communication capabilities and even resume family life. Nevertheless, as a neurosurgical intervention, DBS implantation entails significant surgical risks and potential complications (such as cerebral edema in the surgical area, secondary cerebral hemorrhage, secondary epilepsy, postoperative brain abscess, pulse generator shutdown or circuit malfunction, displacement of stimulation electrodes or extension leads, rejection reactions), and incurs substantial costs, imposing a heavy burden on patients' families and the national medical insurance fund. Traditional non-invasive brain stimulation methods, such as transcranial alternating or direct current stimulation, although not requiring surgery, have limited focusing capacity and the ability to stimulate deep brain structures. Hence, researchers have been in pursuit of approaches to precisely and effectively stimulate deep brain regions without the need for surgery.

In 2017, the concept of temporal interference (TI) stimulation, a novel non-invasive method for regulating deep brain regions was put forward . The fundamental principle of TI stimulation is that two interfering high-frequency signals will generate a low-frequency amplitude-modulated electric field, which can drive the discharge of deep brain neurons. Furthermore, by fixing the sum of the input currents of two pairs of electrodes and altering the current input ratio of the two pairs of electrodes, the movement of the mouse's forepaws, whiskers, and ears without modifying the spatial position of the electrodes could be achieved. Therefore, TI stimulation enables the flexible movement of the stimulation target area within the brain without electrode displacement. Despite the fact that research on TI technology is still in its nascent stage, this method has demonstrated substantial potential in neuroscience and clinical therapy.

Consequently, the objective of this multicenter randomized controlled trial is to assess the therapeutic effect of temporal interference stimulation in awakening patients with severe disorders of consciousness and verify its safety. Simultaneously, it aims to clarify issues such as the clinical application indications, operational parameters of TI. This will facilitate a deeper comprehension of the effectiveness, clinical application indications, operational parameters, and treatment plans of this emerging neuro-modulation technology as a means of awakening treatment, and promote the advancement of diagnosis and treatment technologies for patients with severe disorders of consciousness.