High-definition transcranial electrical stimulation (HD-tES) is a non-invasive brain neuromodulation technique that applies a small electrical current to the scalp to alter neural excitability and stimulate localized brain activation. Previous clinical trials have explored the use of HD-tES for treating mental health conditions such as depression, anxiety, obsessive-compulsive disorder, and post-traumatic stress disorder. This trial aims to investigate the efficacy and safety of HD-tES in ameliorating anxiety symptoms among patients with generalized anxiety disorder (GAD), thereby validating its potential as a treatment for anxiety disorders.
Participants will be randomly assigned to one of four HD-tES treatment groups: (1) HD-tES inhibitory waveform (cDC+cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. (2) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (3) HD-tES inhibitory waveform (cDC+cTBS) applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (4) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. Regardless of the group assignment, participants will undergo treatment sessions over a 2-week period, with five sessions per week and no more than one session per day. Each session lasts approximately 20 minutes. Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Age between 18 and 65 years.
Diagnosed with Generalized Anxiety Disorder (GAD) by a psychiatrist according to DSM-5 criteria.
Hamilton Anxiety Rating Scale (HAM-A) score ≥ 14.
Hamilton Depression Rating Scale (HAM-D; 17-item version) score ≤ 17.
Received rTMS or any other form of non-invasive brain stimulation techniques within 2 weeks prior to the study and during the study period.
Presence of severe neurological disorders (e.g., stroke, brain tumor, epilepsy, organic brain diseases) or psychiatric disorders (e.g., schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, other types of anxiety disorders, substance abuse).
Severe or unstable physiological conditions that may affect the autonomic or central nervous system (e.g., acute gastrointestinal diseases, cardiovascular diseases, thyroid disorders).
History of cardiac arrhythmia.
Parallel
HD-R_cDC+cTBS & sham-L_aDC+iTBS
DeviceHD-tES inhibitory waveform (cDC+cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes.
sham-R_cDC+cTBS & HD-L_aDC+iTBS
DeviceSham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes.
HD-R_cDC+cTBS & HD-L_aDC+iTBS
DeviceHD-tES inhibitory waveform (cDC+cTBS) applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes.
sham-R_cDC+cTBS & sham-L_aDC+iTBS
DeviceSham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes.
Change in severity of anxious symptoms as assessed by Hamilton Anxiety Rating Scale (HAM-A) and after intervention
Change in state and trait anxiety as assessed by State-Trait Anxiety Inventory (STAI) after intervention
Change in severity of depressive symptoms as assessed by Hamilton Depression Scale (HAM-D) after intervention
Change in sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) after intervention
Self-rated anxiety level as assessed by Visual Analog Scale (VAS)
Heart Rate Variability (HRV) as assessed by NeXus-10MK Ⅱ
Change in working memory ability as assessed by N-back task after intervention
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