Multimodal Clinical Study of Electroconvulsive Therapy and Magnetic Seizure Therapy

March 10, 2026 updated by: Yanghua Tian, The Second Hospital of Anhui Medical University
To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yanghua Tian PhD
  • Phone Number: 0551 6599 7278
  • Email: zylykd@163.com

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Patients Inclusion Criteria:

Aged 12-80 years; Diagnosis confirmed by two psychiatrists per DSM-5; Stable medication regimen pre-enrollment; Indicated for neuromodulation OR with visual field defects.

Patients Exclusion Criteria:

Major systemic diseases; Prior neuromodulation within 3 months; Pregnancy or potential pregnancy; Metal implants or claustrophobia.

Healthy Control Inclusion Criteria:

Aged 12-80 years; No history of neuropsychiatric disorders; No significant systemic diseases; Normal or corrected vision.

Healthy Control Exclusion Criteria:

Metal implants or claustrophobia; Ocular diseases or surgery history.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroconvulsive Therapy (ECT) Group
Participants with Major Depressive Disorder(MDD) receive active Electroconvulsive Therapy (ECT) according to the study protocol, in addition to their ongoing standardized pharmacotherapy. This group assesses the efficacy and cognitive effects of ECT.
Device: Electroconvulsive Therapy
Electroconvulsive therapy will be administered two to four times a week according to a standardized protocol. Stimulation parameters (including intensity, target location, session number, and duration) will be individualized for each participant based on prior research to ensure targeted and safe delivery within established safety limits. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.
Other: Cognitive and Behavioral Assessment
Participants will undergo a series of standardized cognitive tests (e.g., MCCB) and behavioral assessments (e.g., clinical rating scales) at specified time points. This does not constitute a therapeutic intervention but is for the purpose of data collection to establish normative baseline performance.
Experimental: Magnetic Seizure Therapy (MST) Group
Participants with Major Depressive Disorder (MDD) receive active Magnetic Seizure Therapy (MST) according to the study protocol, in addition to their ongoing standardized pharmacotherapy. This group assesses the efficacy and cognitive effects of MST, allowing for comparison with ECT.
Other: Cognitive and Behavioral Assessment
Participants will undergo a series of standardized cognitive tests (e.g., MCCB) and behavioral assessments (e.g., clinical rating scales) at specified time points. This does not constitute a therapeutic intervention but is for the purpose of data collection to establish normative baseline performance.
Device: Magnetic Seizure Therapy
Magnetic seizure therapy will be administered two to four times a week according to a standardized protocol. Stimulation parameters (including intensity, target location, session number, and duration) will be individualized for each participant based on prior research to ensure targeted and safe delivery within established safety limits. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.
Other: Healthy Control Group
Healthy volunteers with no history of major neuropsychiatric disorders. They do not receive any neuromodulation intervention (ECT or MST) or study-related pharmacotherapy. They undergo the same cognitive and behavioral assessments at matched time points to provide normative baseline data for comparison.
Other: Cognitive and Behavioral Assessment
Participants will undergo a series of standardized cognitive tests (e.g., MCCB) and behavioral assessments (e.g., clinical rating scales) at specified time points. This does not constitute a therapeutic intervention but is for the purpose of data collection to establish normative baseline performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hamilton Depression Rating Scale Total Score.
Time Frame: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
The Hamilton Depression Rating Scale is a clinician-administered scale used to assess the severity of depressive symptoms. The 17-item version (HAMD-17) is most common. Each item is rated on a 3- or 5-point scale. The total score ranges from 0 to 52, with a higher score indicating more severe depression. The primary endpoint is the change in total score from baseline.
Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
Change in heart rate variability (HRV) parameters derived from electrocardiogram (ECG).
Time Frame: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
ECG recordings will be analyzed to assess changes in heart rate variability (HRV) as a potential biomarker of autonomic nervous system function in response to treatment. Key parameters include the root mean square of successive differences (RMSSD) and the standard deviation of NN intervals (SDNN).
Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
Change in Hamilton Anxiety Rating Scale Total Score.
Time Frame: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
The HAMA is a 14-item clinician-rated scale assessing anxiety severity. Total score ranges from 0 to 56, with higher scores indicating worse anxiety. The change from baseline to the end of treatment will be the primary measure of clinical efficacy.
Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
Change in the Overall Composite Score of the MATRICS Consensus Cognitive Battery.
Time Frame: Baseline and after the completion of the last session (an average of 2 weeks).
The MCCB is a standardized, performance-based cognitive battery used to assess global cognitive functioning. The primary measure is the change in the Overall Composite T-score (derived from 10 tests across 7 domains), with higher scores indicating better cognitive performance. Assessments are administered by trained personnel.
Baseline and after the completion of the last session (an average of 2 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in resting-state brain activity in specific brain regions.
Time Frame: Baseline and after the completion of the last session (an average of 2 weeks).
This will be assessed by measuring changes in functional connectivity (FC) OR the amplitude of low-frequency fluctuations (ALFF) within specific brain regions.
Baseline and after the completion of the last session (an average of 2 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Anhui Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 7, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHMU-MST/ECT-MDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have not yet finalized a plan for IPD sharing. A decision regarding data sharing, including the types of data to be shared, the timing, and the access procedures, will be made prior to the completion of the study and will be documented in the statistical analysis plan (SAP) or a separate data sharing plan. Any updates will be reflected in the registry record.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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