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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Device: Active ON-tDCS; Device: Sham ON-tDCS

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huang, Manli, M.D; Phone Number: 86 13957162975; Email: huangmanli@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310009
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University
      • Contact: Huang Manli, M.D; Phone Number: 86 13957162975; Email: huangmanli@zju.edu.cn
      • Contact: Chen Jingkai, B.D; Phone Number: 86 18667045770; Email: wzcjk922@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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 Comparator: 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.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Depression; transcranial direct current stimulation; the locus coeruleus-noradrenergic circuit
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: IIT20221169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No