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

NCT ID: NCT05634941

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-10-01

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Active ON-tDCS

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

Sham ON-tDCS

Intervention Type: DEVICE

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Zhejiang University

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huang, Manli, M.D

Role: CONTACT

huangmanli@zju.edu.cn

13957162975 ext. 86

Facility Contacts

Huang Manli, M.D

Role: primary

huangmanli@zju.edu.cn

13957162975 ext. 86

Chen Jingkai, B.D

Role: backup

wzcjk922@163.com

18667045770 ext. 86

Other Identifiers

IIT20221169

Identifier Type: -

Identifier Source: org_study_id