Back to resultsEffect of ON-tDCS on Memory Function Improvement and Related Circuits in Stable Depression Patients
Primary Purpose
Depression
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active ON-tDCS
Sham ON-tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, transcranial direct current stimulation, the locus coeruleus-noradrenergic circuit
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- The First Affiliated Hospital of Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active ON-tDCS
Sham ON-tDCS
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT05634941
First Posted
November 22, 2022
Last Updated
November 22, 2022
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05634941
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, transcranial direct current stimulation, the locus coeruleus-noradrenergic circuit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active ON-tDCS
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham ON-tDCS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Active ON-tDCS
Intervention Description
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
Intervention Name(s)
Sham ON-tDCS
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in working memory test scores after intervention.
Description
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.
Time Frame
Baseline, 2-week, 2-month
Secondary Outcome Measure Information:
Title
Change in three component test of executive function scores after intervention.
Description
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.
Time Frame
Baseline, 2-week, 2-month
Title
Change in the test of logical memory on the Wechsler Memory Test score after intervention.
Description
The test asked participants to retell a story they had heard and rate how well they recalled it
Time Frame
Baseline, 2-week, 2-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang, Manli, M.D
Phone
13957162975
Ext
86
Email
huangmanli@zju.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Manli, M.D
Phone
13957162975
Ext
86
Email
huangmanli@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Chen Jingkai, B.D
Phone
18667045770
Ext
86
Email
wzcjk922@163.com
12. IPD Sharing Statement
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Effect of ON-tDCS on Memory Function Improvement and Related Circuits in Stable Depression Patients
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