A Randomized Controlled Study of Transcranial Temporal Interference Electrical Stimulation for Consciousness Recovery in Patients with Prolonged Disorders of Consciousness and Exploration of Its Mechanisms

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: tTIS group (intervention group):Transcranial temporal interference stimulation (tTIS) combined with conventional treatment.;sham tTIS group (control group):sham tTIS stimulation combined with conventional treatment.; CONDITION: prolonged disorders of consciousness (pDOC) PRIMARY OUTCOME: improvement rate of the level of consciousness;The incidence of adverse events (AEs) and serious adverse events (SAEs) related to tTIS treatment.; SECONDARY OUTCOME: electroencephalography (EEG)‐related parameters;Functional magnetic resonance imaging (fMRI)‐related parameters;serum biomarkers of consciousness level;functional near‐infrared spectroscopy (fNIRS)‐related parameters;CRS‐R, GCS, FOUR, GOSE; INCLUSION CRITERIA: 1.Aged 18 to 80 years; 2.Patients clinically diagnosed as vegetative state (VS) or minimally conscious state (MCS) based on the Coma Recovery Scale‐Revised (CRS‐R) assessment. 3.Disease duration >= 28 days and < 1 year; 4.Patients with disorders of consciousness (DoC) caused by traumatic brain injury, stroke, or hypoxic encephalopathy. 5.Informed consent obtained from the patient's legal guardian.
Epistemonikos ID: b8ae37d6c62c24c8237453bf6fc1392641af7964
First added on: Oct 08, 2026