Study Results
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Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-01-01
2025-12-31
Brief Summary
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Detailed Description
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Electroconvulsive therapy depends on the number of treatments, usually 2-3 times a week, for a total of 6-12 treatments. Studies have shown early mood improvement after the third ECT. The investigators propose a new ECT treatment strategy, which involves sequential hybridization of high definition transcranial direct current stimulation (HD-tDCS) after the third ECT to maintain its efficacy while mitigating cognitive side effects.
60 patients with depressive disorder diagnosed by Diagnostic and Statistical Manual of Mental Disorders(DSM-5) were recruited from the fourth people's Hospital of Hefei and the Second Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before treatments. After meeting the inclusion criteria and obtaining informed consent, All the participants were randomized (1:1:1) into three groups: ECT combined with real stimulation tDCS group, ECT combined with sham stimulation tDCS group, and ECT full course group.
For ECT combined with real stimulation tDCS group, Bifrontal short-pulse ECT was performed once a day for 3 consecutive days. Then,tDCS stimulates the dorsomedial prefrontal cortex. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. 2 milliampere(mA) (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes Twice a day over 10 consecutive sessions.
For ECT combined with sham stimulation tDCS group,Bifrontal short-pulse ECT was performed once a day for 3 consecutive days.Then,Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
For ECT full course group,Bifrontal short-pulse ECT was performed once a day for 3 consecutive days, then once every other day, for a total of 6 times,as a traditional contrast Emotional and memory function assessments were conducted at three time points: baseline, post-ECT, and post-TDCS. Emotional assessments included Hamilton Rating Scale for Depression(HAMD), Hamilton Anxiety Scale(HAMA), Beck Scale For Suicide Ideation(BSS), Patient Health Questionnaire-15(PHQ15), Ruminative Responses Scale(RRS), The Temporal Experience of Pleasure Scale (TEPS) and The Positive and Negative Affect Scale(PANAS). Memory function assessments included association memory and working memory.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ECT combined with real stimulation tDCS group
Bifrontal short-pulse ECT was performed once a day for 3 consecutive days. Then,tDCS stimulates the dorsomedial prefrontal cortex. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. 2-mA (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes Twice a day over 10 consecutive sessions.
High definition transcranial direct current stimulation
tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, constant current applied directly to the head through scalp electrodes.
electroconvulsive therapy device
ECT induces brief generalized epileptic seizures by electric current to stimulate the forehead under general anesthesia
ECT combined with sham stimulation tDCS group
Bifrontal short-pulse ECT was performed once a day for 3 consecutive days. Then,Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Sham High definition transcranial direct current stimulation
Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
electroconvulsive therapy device
ECT induces brief generalized epileptic seizures by electric current to stimulate the forehead under general anesthesia
ECT full course group
The ECT full corse group was used as a standard control.Bifrontal short-pulse ECT was performed once a day for 3 consecutive days,and then once every other day, for a total of 6 times.
electroconvulsive therapy device
ECT induces brief generalized epileptic seizures by electric current to stimulate the forehead under general anesthesia
Interventions
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High definition transcranial direct current stimulation
tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, constant current applied directly to the head through scalp electrodes.
Sham High definition transcranial direct current stimulation
Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
electroconvulsive therapy device
ECT induces brief generalized epileptic seizures by electric current to stimulate the forehead under general anesthesia
Eligibility Criteria
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Inclusion Criteria
* Meets the ECT treatment indication
* the age ranged from 18 to 60 years old, and the length of education was more than 5 years.
* the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.
Exclusion Criteria
* accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women.
* accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.
* with a history of ECT treatment within the past 3 months
18 Years
60 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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WANG KAI
Director of medical psychological department, Anhui Medical University
Principal Investigators
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Yanghua Tian, PhD
Role: STUDY_CHAIR
Anhui Medical University
Locations
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Anhui Medical University
Hefei, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AHMU-ECT-TDCS-MDD
Identifier Type: -
Identifier Source: org_study_id
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