Transcranial Direct Current StimulationNCT06109480
Effect of HD-tDCS Assisted ECT for Depression Disorder
A study testing High definition transcranial direct current stimulation and electroconvulsive therapy device in people with Transcranial Direct Current Stimulation and Electroconvulsive Therapy, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) assisted Electroconvulsive Therapy (ECT) for depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Electroconvulsive Therapy, Depressive Disorder
- What is being tested?
- High definition transcranial direct current stimulation and electroconvulsive therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei
Kai Wang, PhD, +86055162923704, wangkai1964@126.com
Yanghua Tian, PhD, +86055162923704, ayfytyh@126.com
About this study
Official title: Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) Assisted Electroconvulsive Therapy (ECT) for Depression Disorder
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) assisted Electroconvulsive Therapy (ECT) for depressive disorder.
Read the detailed 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.
- Being tested
- High definition transcranial direct current stimulation, Sham High definition transcranial direct current stimulation, electroconvulsive therapy device
- Keywords
- Transcranial Direct Current Stimulation, Electroconvulsive therapy, Depressive Disorder
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition transcranial direct current stimulationDevice
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 stimulationDevice
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 deviceDevice
ECT induces brief generalized epileptic seizures by electric current to stimulate the forehead under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| ECT combined with real stimulation tDCS group | Active comparator | 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. Receives: Device: High definition transcranial direct current stimulation; Device: electroconvulsive therapy device |
| ECT combined with sham stimulation tDCS group | Sham comparator | 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. Receives: Device: Sham High definition transcranial direct current stimulation; Device: electroconvulsive therapy device |
| ECT full course group | Other | 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. Receives: Device: electroconvulsive therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
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.
Measured: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
Secondary outcomes (3)
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.
Measured: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
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.
Measured: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
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.
Measured: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
- Investigators
- Yanghua Tian, PhD, Study chair, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109480
- Sponsor's protocol ID
- AHMU-ECT-TDCS-MDD
- Status last verified
- Nov 2023
- First submitted
- 21 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) Assisted Electroconvulsive Therapy (ECT) for Depression Disorder
- ClinicalTrials.gov ID
- NCT06109480
- Acronym / sponsor ID
- AHMU-ECT-TDCS-MDD
- Keywords
- Transcranial Direct Current Stimulation, Electroconvulsive therapy, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) assisted Electroconvulsive Therapy (ECT) for depressive disorder.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECT combined with real stimulation tDCS group | Active comparator | Device: High definition transcranial direct current stimulation, Device: electroconvulsive therapy deviceBifrontal 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. |
| ECT combined with sham stimulation tDCS group | Sham comparator | Device: Sham High definition transcranial direct current stimulation, Device: electroconvulsive therapy deviceBifrontal 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. |
| ECT full course group | Other | Device: electroconvulsive therapy deviceThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High definition transcranial direct current stimulationtDCS 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. | Device | ECT combined with real stimulation tDCS group |
| Sham High definition transcranial direct current stimulationSham 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. | Device | ECT combined with sham stimulation tDCS group |
| electroconvulsive therapy deviceECT induces brief generalized epileptic seizures by electric current to stimulate the forehead under general anesthesia | Device | ECT combined with real stimulation tDCS group, ECT combined with sham stimulation tDCS group, ECT full course group |
Primary outcome
Change in Hamilton Depression Rating Scale (HAMD) Score
Time frame: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
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.
Change in Associative Memory
Time frame: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
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.
3 secondary outcomes
Change in Hamilton Anxiety Scale (HAMA) Score
Time frame: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
Change in the Patient Health Questionnaire-15 (PHQ-15) scale
Time frame: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
Change in Working Memory
Time frame: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanghua Tian, PhD study chair
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High definition transcranial direct current stimulation and electroconvulsive therapy device in people with Transcranial Direct Current Stimulation and Electroconvulsive Therapy, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, PhD (+86-0551-62923704, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (HAMD) Score (time frame: baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.