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

Zhejiang University

Status: Enrolling

Conditions: Depression

Treatments: Device: Sham ON-tDCS; Device: Active ON-tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05634941

IIT20221169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Active ON-tDCS

Active Comparator group

Description:

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.

Treatment:

Device: Active ON-tDCS

Sham ON-tDCS

Sham Comparator group

Description:

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.

Treatment:

Device: Sham ON-tDCS