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)

NCT07533773 | Not Yet Recruiting

• 1 other identifier: AHMU-FNIRS-MDD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder; Electroconvulsive Therapy; Magnetic Seizure Therapy; Functional Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline and immediately after the intervention

• 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.

  baseline and immediately after the intervention

Secondary Outcomes (3)

• Self-Rating Depression Scale

  Baseline and immediately after intervention

• Hamilton Anxiety Rating Scale

  Baseline and immediately after intervention

• 15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire

  Baseline and immediately after intervention

Study Arms (2)

ECT group

ACTIVE COMPARATOR

The patient will undergo at least three sessions of electroconvulsive therapy (ECT).

Other: Electroconvulsive Therapy

MST group

ACTIVE COMPARATOR

The patient will undergo at least three sessions of magnetic seizure therapy (MST).

Other: Magnetic Seizure Therapy

Interventions

Electroconvulsive Therapy OTHER

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.

ECT group

Magnetic Seizure Therapy OTHER

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.

MST group

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Receipt of ECT or MST treatment within the past six months.

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Yanghua Tian

CONTACT

+86-13955188448; tianyh@ahmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of the First Affiliated Hospital of the University of Science and Technology of China

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

CN (1)