An interventional study of TI Stimulation and Sham Stimulation in Disorder of Consciousness and Temporal Interference Stimulation, sponsored by Huashan Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment
Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.
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.
236 studies on the registry are indexed under Consciousness Disorders; 102 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 147 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.
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Exclusion Criteria:
The two high-frequency electric fields of the TI device are set at different frequencies, thereby resulting in the generation of a low-frequency electric field that is capable of triggering brain physiological responses. The duration is 10 minutes.
Procedure: TI Stimulation
The two high-frequency electric fields of the TI device are set to be completely of the same frequency (2000Hz), thus no low-frequency electric field is produced and no cerebral physiological responses are elicited. The duration lasts for 10 minutes.
Procedure: Sham Stimulation
Participants will accept the TI stimulus for one month
Participants will accept the sham TI stimulus for one month
Effective rate of awakening
The CRS-R is employed, with a minimum of 5 CRS-R assessments conducted at each follow-up time point, accompanied by simultaneous video recording. And the highest value is scored as a state of consciousness. The clinical assessment of participants' consciousness is deemed significantly improved when it fulfills the following criteria: a) MCS- recover to consciousness level of MCS+ or higher; b) Vegetative state(VS) recover to consciousness level of MCS- or higher; c) MCS status (MCS- or MCS+) recover to emergence from MCS (restoration of functional communication).
Time frame: Stimulation for 1 month
The difference of CRS-R scale relative to baseline between TI group and sham group
The Coma Recovery Scale-Revised (CRS-R) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. It has good validity, reliability and practicability.
Time frame: Stimulation begin for 14 days, 1 month and 3 months
The difference of Simplified Evaluation of CONsciousness Disorders (SECONDs) scale relative to baseline between TI group and sham group
The SECONDs is a fast tool to assess consciousness in brain-injured patients. The minimum score is 0 and the maximum is 8, higher scores mean a better outcome.
Time frame: Stimulation begin for 14 days, 1 month and 3 months
The difference of modified Ashworth scale relative to baseline between TI group and sham group
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone. The minimum grade is 0 and the maximum is 4, higher scores mean a worse outcome.
Time frame: Stimulation begin for 14 days, 1 month and 3 months
The difference of Nociception Coma Scale-Revised (NCS-R) scale relative to baseline between TI group and sham group
The NCS-R was developed to help assess pain in patients with disorders of consciousness (DOC). Several studies have shown its sensitivity in assessing response to acute noxious stimuli. The minimum score is 0 and the maximum is 12, higher scores mean a better outcome.
Time frame: Stimulation begin for 14 days, 1 month and 3 months
The difference of effective rate of awakening between TI group and sham group by CRS-R scale
The Coma Recovery Scale-Revised (CRS-R) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. It has good validity, reliability and practicability.
Time frame: Stimulation begin for 1 month and 3 months
The difference of effective rate of awakening between TI group and sham group by Simplified Evaluation of CONsciousness Disorders (SECONDs) scale
The SECONDs is a fast tool to assess consciousness in brain-injured patients. The minimum score is 0 and the maximum is 8, higher scores mean a better outcome.
Time frame: Stimulation begin for 1 month and 3 months
The difference of recovery trajectories of consciousness level between TI group and Sham group
Time frame: Stimulation for 3-month-stimulation
Plan to share: No
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