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

NCT05634941 | Unknown

• 1 other identifier: IIT20221169
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; transcranial direct current stimulation; the locus coeruleus-noradrenergic circuit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in three component test of executive function scores after intervention.

  Baseline, 2-week, 2-month

• Change in the test of logical memory on the Wechsler Memory Test score after intervention.

  Baseline, 2-week, 2-month

Study Arms (2)

Active ON-tDCS

ACTIVE COMPARATOR

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

Sham ON-tDCS

SHAM COMPARATOR

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

Interventions

Active ON-tDCS 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.

Active ON-tDCS

Sham ON-tDCS 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).

Sham ON-tDCS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible for ICD-10 depressive episode (F32) or recurrent depressive disorder (F33) diagnosis;
• Antidepressant therapy for at least 8 weeks, with no antidepressant adjustment for nearly 2 months
• HAMD-17 scores ≤ 7 points at the time of enrollment; CGI score ≦2;
• Chief complaint of memory impairment, PDQ-D score of cognitive impairment ≧17 points;
• Right-handed.

You may not qualify if:

• A history of major physical diseases;
• Have other mental disorders that meet the diagnostic criteria of ICD-10;
• Hearing, color blindness, color weakness or receive electroconvulsive therapy;
• Alcohol dependence or substance abuse;
• Patients with intellectual disability;
• Pregnant or lactating women or those planning to become pregnant;
• Patients with contraindications to tDCS.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hanzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Huang, Manli, M.D

CONTACT

13957162975; huangmanli@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: October 1, 2024
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

CN (1)