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Effect of ON-tDCS on Memory Function Improvement and Related Circuits in Stable Depression Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05634941
Enrollment
60
Registered
2022-12-02
Start date
2022-10-01
Completion date
2024-10-01
Last updated
2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, transcranial direct current stimulation, the locus coeruleus-noradrenergic circuit

Brief 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 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.

Interventions

DEVICEActive ON-tDCS

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.

DEVICESham ON-tDCS

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).

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. Eligible for ICD-10 depressive episode (F32) or recurrent depressive disorder (F33) diagnosis; 2. Antidepressant therapy for at least 8 weeks, with no antidepressant adjustment for nearly 2 months 3. HAMD-17 scores ≤ 7 points at the time of enrollment; CGI score ≦2; 4. Chief complaint of memory impairment, PDQ-D score of cognitive impairment ≧17 points; 5. Right-handed.

Exclusion criteria

1. A history of major physical diseases; 2. Have other mental disorders that meet the diagnostic criteria of ICD-10; 3. Hearing, color blindness, color weakness or receive electroconvulsive therapy; 4. Alcohol dependence or substance abuse; 5. Patients with intellectual disability; 6. Pregnant or lactating women or those planning to become pregnant; 7. Patients with contraindications to tDCS.

Design outcomes

Primary

MeasureTime frameDescription
Change in working memory test scores after intervention.Baseline, 2-week, 2-monthThe 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.

Secondary

MeasureTime frameDescription
Change in three component test of executive function scores after intervention.Baseline, 2-week, 2-monthThe 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.
Change in the test of logical memory on the Wechsler Memory Test score after intervention.Baseline, 2-week, 2-monthThe test asked participants to retell a story they had heard and rate how well they recalled it

Countries

China

Contacts

Primary ContactHuang, Manli, M.D
huangmanli@zju.edu.cn13957162975

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026