DepressionNCT05634941
Effect of ON-tDCS on Memory Function Improvement and Related Circuits in Stable Depression Patients
A study testing Active ON-tDCS in people with Depression, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
So far, antidepressant drugs have limited memory improvement. Transcranial direct current stimulation, as a non-invasive and safe neuroregulatory technique, is a new direction to improve memory.In this study, transcranial direct current stimulation of the greater occipital nerve was used to explore the effect of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Active ON-tDCS
- 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 Oct 2022to 1 Oct 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible for ICD-10 depressive episode (F32) or recurrent depressive disorder (F33) diagnosis;
- Antidepressant therapy for at least 8 weeks, with no antidepressant adjustment for nearly 2 months
- HAMD-17 scores ≤ 7 points at the time of enrollment; CGI score ≦2;
- Chief complaint of memory impairment, PDQ-D score of cognitive impairment ≧17 points;
- Right-handed.
Who cannot join
- A history of major physical diseases;
- Have other mental disorders that meet the diagnostic criteria of ICD-10;
- Hearing, color blindness, color weakness or receive electroconvulsive therapy;
- Alcohol dependence or substance abuse;
- Patients with intellectual disability;
- Pregnant or lactating women or those planning to become pregnant;
- Patients with contraindications to tDCS.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hanzhou, Zhejiang, 310009
Huang Manli, M.D, 13957162975 ext. 86, huangmanli@zju.edu.cn
Chen Jingkai, B.D, 18667045770 ext. 86, wzcjk922@163.com
About this study
Official title: Effect of Transcranial Direct Current Stimulation of the Greater Occipital Nerve on Memory Function Improvement and and the Locus Coeruleus-Noradrenergic Circuits in Stable Depression Patients
So far, antidepressant drugs have limited memory improvement. Transcranial direct current stimulation, as a non-invasive and safe neuroregulatory technique, is a new direction to improve memory.In this study, transcranial direct current stimulation of the greater occipital nerve was used to explore the effect of improving memory function in patients with stable depression, and related studies were conducted on the locus coeruleus-noadrenal loop and the functional connection between locus coeruleus, hippocampus and amygdala.
Read the detailed description
In this study, a randomized, controlled, double-blind design was adopted. Patients with depression were randomly divided into an intervention group and a control group to receive true or fake tDCS stimulation respectively. Clinical data, memory and other related cognitive function assessment, EEG, resting state fMRI, saliva and blood indicators were collected two weeks before and two weeks after the intervention, and followed up for eight weeks. Finally, data correlation analysis was performed.
- Conditions
- Depression
- Being tested
- Active ON-tDCS, Sham ON-tDCS
- Keywords
- Depression, transcranial direct current stimulation, the locus coeruleus-noradrenergic circuit
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ON-tDCSDevice
DC was transmitted via a saline-soaked pair of surface sponges and delivered by specially developed, battery-driven, constant current stimulator with a maximum output of 2 mA. For each participant receiving ON-tDCS, the anodal electrode placed over the left C2 nerve dermatome, and cathodal electrode placed over the right C2 dermatome. A constant current of 1.5 mA was applied for 20 min.
Sham ON-tDCSDevice
For sham group, placement of the electrodes was identical to that of active ON-tDCS. ON-tDCS was first switched on in a ramp-up fashion over 5 s. Current intensity (ramp down) was gradually reduced (over 5 s) as soon as ON-tDCS reached a current flow of 1.5 mA. Hence, sham ON-tDCS only lasted 10 s (as opposed to 20 min in the active group).
| Study group | Role | What they receive |
|---|---|---|
| Active ON-tDCS | Active comparator | The active group will receive the active transcranial direct current stimulation via a saline-soaked pair of surface sponges. Patients received this treatment protocol for 5 consecutive days. Receives: Device: Active ON-tDCS |
| Sham ON-tDCS | Sham comparator | The sham group will also receive the transcranial direct current stimulation for 5 consecutive days on sham procedure. The rationale behind this sham procedure was to mimic the transient skin sensation at the beginning of active ON-tDCS without producing any conditioning effects on the brain. Receives: Device: Sham ON-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in working memory test scores after intervention.
The working memory test consists of two parts, which measure the breadth and accuracy of working memory respectively. The breadth of working memory will be tested using the operating span experiment, as the accuracy of working memory will be tested using the Memory Orientation experiment.
Measured: Baseline, 2-week, 2-month
Secondary outcomes (2)
Change in three component test of executive function scores after intervention.
The three component tests of executive function were one-backward test, anti-saccade and shifting test respectively.In the one-backward test, subjects need to memorize letters while counting numbers, scoring them according to the accuracy of the alphabetic memory order; The anti-saccade test asks subjects to react to a flash of arrows (0.5 seconds) by selecting the direction they see on a keyboard；The shifting test asked subjects to select a forward or reverse feedback key depending on where the icon appeared.
Measured: Baseline, 2-week, 2-month
Change in the test of logical memory on the Wechsler Memory Test score after intervention.
The test asked participants to retell a story they had heard and rate how well they recalled it
Measured: Baseline, 2-week, 2-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634941
- Sponsor's protocol ID
- IIT20221169
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation of the Greater Occipital Nerve on Memory Function Improvement and and the Locus Coeruleus-Noradrenergic Circuits in Stable Depression Patients
- ClinicalTrials.gov ID
- NCT05634941
- Acronym / sponsor ID
- IIT20221169
- Conditions
- Depression
- Keywords
- Depression, transcranial direct current stimulation, the locus coeruleus-noradrenergic circuit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 2 Dec 2022 (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.
So far, antidepressant drugs have limited memory improvement. Transcranial direct current stimulation, as a non-invasive and safe neuroregulatory technique, is a new direction to improve memory.In this study, transcranial direct current stimulation of the greater occipital nerve was used to explore the effect of improving memory function in patients with stable depression, and related studies were conducted on the locus coeruleus-noadrenal loop and the functional connection between locus coeruleus, hippocampus and amygdala.
Detailed description
In this study, a randomized, controlled, double-blind design was adopted. Patients with depression were randomly divided into an intervention group and a control group to receive true or fake tDCS stimulation respectively. Clinical data, memory and other related cognitive function assessment, EEG, resting state fMRI, saliva and blood indicators were collected two weeks before and two weeks after the intervention, and followed up for eight weeks. Finally, data correlation analysis was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active ON-tDCS | Active comparator | Device: Active ON-tDCSThe active group will receive the active transcranial direct current stimulation via a saline-soaked pair of surface sponges. Patients received this treatment protocol for 5 consecutive days. |
| Sham ON-tDCS | Sham comparator | Device: Sham ON-tDCSThe sham group will also receive the transcranial direct current stimulation for 5 consecutive days on sham procedure. The rationale behind this sham procedure was to mimic the transient skin sensation at the beginning of active ON-tDCS without producing any conditioning effects on the brain. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Eligible for ICD-10 depressive episode (F32) or recurrent depressive disorder (F33) diagnosis;
- Antidepressant therapy for at least 8 weeks, with no antidepressant adjustment for nearly 2 months
- HAMD-17 scores ≤ 7 points at the time of enrollment; CGI score ≦2;
- Chief complaint of memory impairment, PDQ-D score of cognitive impairment ≧17 points;
- Right-handed.
Key exclusion criteria (7 listed)
- A history of major physical diseases;
- Have other mental disorders that meet the diagnostic criteria of ICD-10;
- Hearing, color blindness, color weakness or receive electroconvulsive therapy;
- Alcohol dependence or substance abuse;
- Patients with intellectual disability;
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 |
|---|---|---|
| Active ON-tDCSDC was transmitted via a saline-soaked pair of surface sponges and delivered by specially developed, battery-driven, constant current stimulator with a maximum output of 2 mA. For each participant receiving ON-tDCS, the anodal electrode placed over the left C2 nerve dermatome, and cathodal electrode placed over the right C2 dermatome. A constant current of 1.5 mA was applied for 20 min. | Device | Active ON-tDCS |
| Sham ON-tDCSFor sham group, placement of the electrodes was identical to that of active ON-tDCS. ON-tDCS was first switched on in a ramp-up fashion over 5 s. Current intensity (ramp down) was gradually reduced (over 5 s) as soon as ON-tDCS reached a current flow of 1.5 mA. Hence, sham ON-tDCS only lasted 10 s (as opposed to 20 min in the active group). | Device | Sham ON-tDCS |
Primary outcome
Change in working memory test scores after intervention.
Time frame: Baseline, 2-week, 2-month
The working memory test consists of two parts, which measure the breadth and accuracy of working memory respectively. The breadth of working memory will be tested using the operating span experiment, as the accuracy of working memory will be tested using the Memory Orientation experiment.
2 secondary outcomes
Change in three component test of executive function scores after intervention.
Time frame: Baseline, 2-week, 2-month
Change in the test of logical memory on the Wechsler Memory Test score after intervention.
Time frame: Baseline, 2-week, 2-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active ON-tDCS in people with Depression, run by First Affiliated Hospital of Zhejiang 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 5 inclusion and 7 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 2 Dec 2022. 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 Huang, Manli, M.D (13957162975 ext. 86, huangmanli@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in working memory test scores after intervention. (time frame: Baseline, 2-week, 2-month). 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 2 Dec 2022.