Effect of HD-tDCS Assisted ECT for Depression Disorder

Depressive Disorder Clinical Trial

Official title:

Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) Assisted Electroconvulsive Therapy (ECT) for Depression Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109480
• Other study ID #: AHMU-ECT-TDCS-MDD
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Anhui Medical University
• Contact: Kai Wang, PhD
• Phone: +86-0551-62923704
• Email: wangkai1964[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) assisted Electroconvulsive Therapy (ECT) for depressive disorder.

Description:

Depression is a mental disorder characterized by low mood, decreased interest, and reduced activity. It affects approximately 350 million people around the world and has become a major public health and social problem. Electroconvulsive therapy (ECT) can quickly and effectively improve depressive symptoms, but it causes severe impairment of cognitive functions, such as reduced face memory. Therefore, improving treatment options is of great significance. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD>17.
• 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 severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Electroconvulsive Therapy
• Transcranial Direct Current Stimulation

Intervention

Device:
• 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

Locations

Country	Name	City	State
China	Anhui Medical University	Hefei

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
Primary	Change in Associative Memory	The associative memory was estimated using a face-cued word association test. In the face-cued word association test, participants studied 12 human face photographs presented individually in grayscale on a computer screen for 4 s per face. Each photograph displayed a unique common word that the participants read aloud as each face-word pair was shown. The participants were instructed to memorize the word associated with each face. After the face-word pairs were presented, participants were shown the same 12 faces, individually and in a different and randomized order. They were asked to recall the words that were presented with each face. Each face was scored as correct or incorrect.These processes are carried out 2 times in total.The average number of successful answers was defined as the associative memory score.	baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
Secondary	Change in Hamilton Anxiety Scale (HAMA) Score	The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.	baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
Secondary	Change in the Patient Health Questionnaire-15 (PHQ-15) scale	The PHQ-15 is a 15-item scale to measure the severity of somatic symptoms, where each item is rated on a scale from 0 to 2. The PHQ-15 total score ranges from 0 to 30, with lower scores indicating less somatic symptoms.	baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
Secondary	Change in Working Memory	The n-back task is one of the most common tasks in working memory studies, involving the storage and manipulation of information. In the 2-back condition, they were required to press a button when the current stimulus matched the stimulus from two trials back; in the 1-back condition, participants pressed a button if the current stimulus matched the immediately preceding stimulus.The n-back task consisted of two block-design functional runs, each of which lasted 336 s.Each run included four block sets, where the 1-back and 2-back conditions were intermixed. The order of blocks in each run was pseudorandomized across participants.The average correct rate in the two conditions was used as an indicator of working memory.	baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)