About this trial
Against the clinical backdrop of the growing global burden of neuropsychiatric disorders, the rapid rise in depression prevalence, and the frequent association of these conditions with cognitive impairment, this study highlights the limitations of current cognitive assessment tools-such as their time-consuming nature and lack of specificity-and underscores the urgent need to develop simple and efficient assessment methods. In terms of treatment, modified electroconvulsive therapy (ECT) and magnetic seizure therapy (MST) are rapidly acting neuromodulation therapies; however, their effects on cognitive function and underlying brain mechanisms remain controversial, and there is a lack of direct comparative studies. Functional near-infrared spectroscopy (fNIRS) technology can non-invasively monitor changes in cerebral hemodynamics, providing a powerful tool for assessing brain function before and after treatment. Therefore, this study aims to combine resting-state and task-based fNIRS with multidimensional cognitive and emotional assessments to systematically compare the effects of ECT and MST on frontal-temporal cerebral hemodynamics. We seek to clarify the differences in brain function regulation between the two treatment modalities and their association with improvements in cognition and mood, with the goal of providing scientific evidence to elucidate the brain mechanisms underlying neurostimulation therapies and optimize individualized treatment plans.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
A depressive episode diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by two psychiatrists;
Meets the treatment criteria for ECT or MST;
At least 5 years of education, with no significant hearing or visual impairments;
Voluntary participation in this study, with a signed written informed consent form, and willingness to cooperate with the collection of general demographic information, neuropsychological testing, and fNIRS resting-state and task-based data acquisition.
Disqualifiers
Co-occurring mental disorders (such as substance use disorders or schizoaffective disorder);
Severe physical illness;
History of neurological disorders (such as traumatic brain injury or dementia);
Low educational attainment;
Trial design
Parallel
Treatments tested in this trial
Electroconvulsive Therapy
Other interventionElectroconvulsive therapy will be administered 2 to 3 times per week according to a standardized protocol. Stimulation parameters-including intensity, target site, number of sessions, and duration-will be individually tailored for each participant based on prior research to ensure targeted and safe delivery within established safety parameters. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.
Magnetic Seizure Therapy
Other interventionMagnetic seizure therapy will be administered 2 to 3 times per week according to a standardized protocol. Stimulation parameters-including intensity, target location, number of sessions, and duration-will be individually tailored for each participant based on prior research to ensure targeted and safe delivery within established safety parameters. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.
Treatment groups
Trial outcomes
Primary outcomes
Change in Hamilton Depression Rating Scale (HAMD) Score
The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.
Differences in frontal and temporal lobe function during cognitive tasks in patients with depression following seizure therapy.
Functional near-infrared spectroscopy (fNIRS) was used to measure hemodynamic responses in the frontal and temporal lobes of patients with depression undergoing electroconvulsive therapy (ECT) or magnetic seizure therapy (MST). Test tasks included a category verbal fluency task (VFT) and a Go/No-Go task.
Secondary outcomes
Self-Rating Depression Scale
Self-Rating Depression Scale (SDS) comprises 20 items with a total score range of 0-100; higher scores indicate more severe depressive symptoms
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale (HAMA) comprises 14 items with a total score range of 0-56; higher scores indicate more severe anxiety symptoms
15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire
15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15) comprises 15 items with a total score of 30; higher scores indicate more severe somatization symptoms
Sponsors and contacts
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