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

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Device: Active ON-tDCS; Device: Sham ON-tDCS

• Registration Number: NCT05634941
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Last Update Submitted: 2022-11-22
• Study First Posted: 2022-12-02
• Last Update Posted: 2022-12-02
• Primary Completion: 2023-12-31
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active ON-tDCS	Active ON-tDCS	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.
Sham ON-tDCS	Sham ON-tDCS	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.

Primary Outcome Measures

Name	Time	Method
Change in working memory test scores after intervention.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hanzhou, Zhejiang, China