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Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Depressive Disorder

Primary Purpose

Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High definition transcranial direct current stimulation
sham high definition transcranial direct current stimulation
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Direct Current Stimulation focused on measuring Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imagin, Depressive Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD>17, BSS>6, PHQ-15>5.
  • the age ranged from 18 to 60 years old, and the length of education was more than 5 years.
  • the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.

Exclusion Criteria:

  • accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
  • accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women.
  • accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.
  • patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc.
  • those who could not cooperate with those who completed the relevant xperiments, such as patients with depressive stupor, claustrophobia and so on.

Sites / Locations

  • Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

real stimulation

sham stimulation

Arm Description

Participants will receive active tDCS once daily for two weeks. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions.

Participants will receive sham tDCS once daily for two weeks. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Outcomes

Primary Outcome Measures

change of depression symptoms of active teatment group
the change of depressive symptoms were assessed by HAMD scale.
change of risk of suicide of active teatment group
the change of risk of suicide was assessed by Beck scale for suicide ideation.
change of somatization symptoms of active teatment group
the change of somatization symptoms were assessed by PHQ- 15 scale.
change of depression symptoms of sham treatment group
the change of depressive symptoms were assessed by HAMD scale.
change of risk of suicide of sham treatment group
the change of risk of suicide was assessed by Beck scale for suicide ideation.
change of somatization symptoms of sham treatment group
the change of somatization symptoms were assessed by PHQ- 15 scale.
Functional MRI measures
the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.
Functional MRI measures
the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2022
Last Updated
March 17, 2022
Sponsor
Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05286645
Brief Title
Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Depressive Disorder
Official Title
Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on suicidal ideation and somatic symptoms in patients with depressive disorder and its underlying neural mechanism by MRI.
Detailed Description
Depressive disorder is a major public health and safety problem around the world. Patients with depression often performe symptoms such as anhedonia, lack of motivation, somatic symptoms, and even suicidal ideation and behavior. The purpose of this study was to study the relieving effect of high definition transcranial direct current stimulation (HD-tDCS) on the symptoms of depression. 60 patients with depressive disorder diagnosed by DSM-5 were recruited from the fourth people's Hospital of Hefei and the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving HD-tDCS. After meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and HD-tDCS treatment conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of Anhui Medical University. All the participants were randomized (1:1) to receive "active" or "sham" treatment protocol. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. Before and after the HD-tDCS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included MoCA, Stroop Test, VFT, DST, AVLT, HAMD, HAMA, PHQ15, BSS(Beck scale for suicide ideation),ISI,SDS, RRS, TEPS, AES, FPQ, PVAQ and AAS. Multimodal fMRI includes 3D-T1, rs-fMRI, DTI and ASL. Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24 hours after the last treatment. The symptoms of the patients were followed up one month after the end of treatment.They were instructed to focus their answers on the past week. Afterwards, they were unblinded by the study coordinator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Depressive Disorder
Keywords
Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imagin, Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real stimulation
Arm Type
Active Comparator
Arm Description
Participants will receive active tDCS once daily for two weeks. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions.
Arm Title
sham stimulation
Arm Type
Placebo Comparator
Arm Description
Participants will receive sham tDCS once daily for two weeks. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Intervention Type
Device
Intervention Name(s)
High definition transcranial direct current stimulation
Intervention Description
tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, constant current applied directly to the head through scalp electrodes.
Intervention Type
Device
Intervention Name(s)
sham high definition transcranial direct current stimulation
Intervention Description
Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Primary Outcome Measure Information:
Title
change of depression symptoms of active teatment group
Description
the change of depressive symptoms were assessed by HAMD scale.
Time Frame
baseline and immediately after the intervention
Title
change of risk of suicide of active teatment group
Description
the change of risk of suicide was assessed by Beck scale for suicide ideation.
Time Frame
baseline and immediately after the intervention
Title
change of somatization symptoms of active teatment group
Description
the change of somatization symptoms were assessed by PHQ- 15 scale.
Time Frame
baseline and immediately after the intervention
Title
change of depression symptoms of sham treatment group
Description
the change of depressive symptoms were assessed by HAMD scale.
Time Frame
baseline and immediately after the intervention
Title
change of risk of suicide of sham treatment group
Description
the change of risk of suicide was assessed by Beck scale for suicide ideation.
Time Frame
baseline and immediately after the intervention
Title
change of somatization symptoms of sham treatment group
Description
the change of somatization symptoms were assessed by PHQ- 15 scale.
Time Frame
baseline and immediately after the intervention
Title
Functional MRI measures
Description
the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.
Time Frame
baseline
Title
Functional MRI measures
Description
the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD>17, BSS>6, PHQ-15>5. the age ranged from 18 to 60 years old, and the length of education was more than 5 years. the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests. Exclusion Criteria: accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on. accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women. accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on. patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc. those who could not cooperate with those who completed the relevant xperiments, such as patients with depressive stupor, claustrophobia and so on.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Wang, PhD
Phone
+86-0551-62923704
Email
wangkai1964@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanghua Tian, PhD
Phone
+8613955188448
Email
ayfytyh@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Zhang
Organizational Affiliation
Anhui Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Anhui Medical University
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YangHua Tian, PhD
Phone
+8613955188448
Email
ayfytyh@126.com
First Name & Middle Initial & Last Name & Degree
Ting Zhang
Phone
+8618356050012
First Name & Middle Initial & Last Name & Degree
Qiangqiang Hou

12. IPD Sharing Statement

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Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Depressive Disorder

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