Multimodal Clinical Study of Electroconvulsive Therapy and Magnetic Seizure Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-80
SponsorThe Second Hospital of Anhui Medical University
About this trial
To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Major systemic diseases;
Prior neuromodulation within 3 months;
Pregnancy or potential pregnancy;
Metal implants or claustrophobia.
Trial design
Design model
Parallel
Treatments tested in this trial
Electroconvulsive Therapy
DeviceElectroconvulsive 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.
Magnetic Seizure Therapy
DeviceMagnetic 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Electroconvulsive Therapy (ECT) GroupExperimental treatment 1 intervention
Group B: Magnetic Seizure Therapy (MST) GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Hamilton Depression Rating Scale Total Score.
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.
Time frame
Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.2
Change in heart rate variability (HRV) parameters derived from electrocardiogram (ECG).
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).
Time frame
Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.3
Change in Hamilton Anxiety Rating Scale Total Score.
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.
Time frame
Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.4
Change in the Overall Composite Score of the MATRICS Consensus Cognitive Battery.
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.
Time frame
Baseline and after the completion of the last session (an average of 2 weeks).Secondary outcomes
1
Change in resting-state brain activity in specific brain regions.
This will be assessed by measuring changes in functional connectivity (FC) OR the amplitude of low-frequency fluctuations (ALFF) within specific brain regions.
Time frame
Baseline and after the completion of the last session (an average of 2 weeks).Sponsors and contacts
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Source ClinicalTrials.gov