Investigating Functional Changes in the Frontotemporal Cortex of Patients With Major Depressive Disorder Following Electroconvulsive Therapy or Magnetic Seizure Therapy Using Functional Near-infrared Spectroscopy (fNIRS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-65
SponsorThe Second Hospital of Anhui Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Electroconvulsive Therapy

    Other intervention

    Electroconvulsive 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 intervention

    Magnetic 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

60 Participants
are divided into 2 treatment groups
Group A: ECT groupActive comparator 1 intervention
Group B: MST groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline and immediately after the intervention
2

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.

Time frame
baseline and immediately after the intervention

Secondary outcomes

1

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

Time frame
Baseline and immediately after intervention
2

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

Time frame
Baseline and immediately after intervention
3

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

Time frame
Baseline and immediately after intervention

Other outcomes

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