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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634941
• Other study ID #: IIT20221169
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2022
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Huang, Manli, M.D
• Phone: 13957162975
• Email: huangmanli[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Active 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.
• Sham 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).

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 2-week, 2-month
Secondary	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.	Baseline, 2-week, 2-month
Secondary	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	Baseline, 2-week, 2-month