Clinical trial NCT05634941: Effect of ON-tDCS on Memory Function Improvement and Related Circuits in Stable Depression Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
transcranial direct current stimulation
the locus coeruleus-noradrenergic circuit
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in working memory test scores after intervention.
timeFrame: Baseline, 2-week, 2-month
Secondary outcomes:
measure: Change in three component test of executive function scores after intervention.
timeFrame: Baseline, 2-week, 2-month
measure: Change in the test of logical memory on the Wechsler Memory Test score after intervention.
timeFrame: Baseline, 2-week, 2-month
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: