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Intervention Effect of High Definition Transcranial Alternating Current Stimulation (HD-tACS) on Depressive Disorder

Primary Purpose

Transcranial Alternating Current Stimulation, Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High definition transcranial alternating current stimulation
sham high definition transcranial alternating 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 Alternating Current Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older 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 65 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

Sites / Locations

  • Yanghua TianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

real stimulation

sham stimulation

Arm Description

The central electrode was placed over F3, with return electrodes at Fp1, Fz, F7 and C3. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 15 and 15 seconds, respectively) were applied for 30 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as IAF.

In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15 and 15 s); no current was delivered during the 30-minute intervention. Participants will receive sham tACS twice daily for two weeks.

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Rating Scale (HAMD) Score
The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.
Change in Beck Scale for Suicide Ideation (BSS) Score
The BSS is a 19-item scale to measure the severity of suicidal ideation, where each item is rated on a scale from 0 to 2. The BSS total score ranges from 0 to 38 with lower scores indicating less suicidal ideation.

Secondary Outcome Measures

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60, with lower scores indicating less depressive symptoms.
Change in Beck Depression Inventory (BDI) Score
The BDI is a 13-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 3. The BDI total score ranges from 0 to 39, with lower scores indicating less depressive symptoms.
Change in Hamilton Anxiety Scale (HAMA) Score
The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.
Change in the Patient Health Questionnaire-15 (PHQ-15) scale
The PHQ-15 is a 15-item scale to measure the severity of somatic symptoms, where each item is rated on a scale from 0 to 2. The PHQ-15 total score ranges from 0 to 30, with lower scores indicating less somatic symptoms.
Change in Montreal Cognitive Assessment (MoCA) Score
We adopted a localized version of MoCA in line with the Chinese cultural background. It includes 11 inspection items in 8 cognitive fields. With a total score of 30 or more than 26, it is normal. Anyone who has been educated for less than 12 years will need to add one point to his final score. A higher score indicates a better outcome.
Change in Auditory Verbal Learning Test (AVLT) Score
We adopted a localized version of AVLT in line with the Chinese cultural background. It includes a 5-trial presentation of a 15-word list (List A), a single presentation of an interference list (List B)(Trial 6), two post-interference recall trials (one immediate - Trial 7, one delayed - Trial 8) and recognition of the target words in the orthographic modality with distractors (Trial 9). Scoring includes the percent score of the mean of Trial 1 through 5, Trial 7, Trial 8 and Trial 9. A higher score indicates a better outcome.
EEG Measure of Frontal Alpha Asymmetry (FFA) Oscillations
EEG recordings were obtained from each subject based on 64 electrode locations of the International 10-20 system (sampling frequency 1000Hz). The change in FFA (8-13 Hz electrical activity) over time was measured.
MRI measures of functional connectivity (FC)
the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.

Full Information

First Posted
May 11, 2023
Last Updated
June 27, 2023
Sponsor
Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05932706
Brief Title
Intervention Effect of High Definition Transcranial Alternating Current Stimulation (HD-tACS) on Depressive Disorder
Official Title
Intervention Effect of High Definition Transcranial Alternating Current Stimulation (HD-tACS) on Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (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 alternating current stimulation (HD-tACS) on suicidal ideation in patients with depressive disorder and its underlying neural mechanism by magnetic resonance imaging (MRI) and electroencephalography (EEG).
Detailed Description
Forty patients with depressive disorder diagnosed by DSM-5 were recruited from the Anhui Mental Health Center and the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving high definition transcranial alternating current stimulation (HD-tACS) treatment after meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, magnetic resonance imaging (MRI), electroencephalography (EEG), and HD-tACS treatment conducted by trained researchers at the Anhui Mental Health Center. All the participants were randomized (1:1) to receive an "active HD-tACS" or "sham HD-tACS" treatment protocol. tACS: the central electrode was placed over F3 with return electrodes placed at Fp1, Fz, F7 and C3. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 15 and 15 seconds, respectively) were applied for 30 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as individual alpha frequency (IAF). Sham HD-tACS 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 15 and 15 seconds. Before and after the treatments, the patients received a battery measure of neuropsychological tests, resting EEG, and MRI scans in multimodalities. The neuropsychological assessment included HAMD, MADRS, BDI, HAMA, BSS, C-SSRS, PHQ15, RRS, TEPS, PVAQ, MoCA, Stroop Test, VFT, DST, and AVLT. Multimodal MRI includes 3D-T1, rs-fMRI, and DTI. The symptoms of the patients were followed up one and two months after the end of treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Alternating Current Stimulation, Depressive Disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
real stimulation
Arm Type
Active Comparator
Arm Description
The central electrode was placed over F3, with return electrodes at Fp1, Fz, F7 and C3. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 15 and 15 seconds, respectively) were applied for 30 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as IAF.
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15 and 15 s); no current was delivered during the 30-minute intervention. Participants will receive sham tACS twice daily for two weeks.
Intervention Type
Device
Intervention Name(s)
High definition transcranial alternating current stimulation
Intervention Description
tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.
Intervention Type
Device
Intervention Name(s)
sham high definition transcranial alternating current stimulation
Intervention Description
In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15s and 15s); no current was delivered during the 30-minute intervention.
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale (HAMD) Score
Description
The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.
Time Frame
baseline and immediately after the intervention
Title
Change in Beck Scale for Suicide Ideation (BSS) Score
Description
The BSS is a 19-item scale to measure the severity of suicidal ideation, where each item is rated on a scale from 0 to 2. The BSS total score ranges from 0 to 38 with lower scores indicating less suicidal ideation.
Time Frame
baseline and immediately after the intervention
Secondary Outcome Measure Information:
Title
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Description
The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60, with lower scores indicating less depressive symptoms.
Time Frame
baseline and immediately after the intervention
Title
Change in Beck Depression Inventory (BDI) Score
Description
The BDI is a 13-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 3. The BDI total score ranges from 0 to 39, with lower scores indicating less depressive symptoms.
Time Frame
baseline and immediately after the intervention
Title
Change in Hamilton Anxiety Scale (HAMA) Score
Description
The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.
Time Frame
baseline and immediately after the intervention
Title
Change in the Patient Health Questionnaire-15 (PHQ-15) scale
Description
The PHQ-15 is a 15-item scale to measure the severity of somatic symptoms, where each item is rated on a scale from 0 to 2. The PHQ-15 total score ranges from 0 to 30, with lower scores indicating less somatic symptoms.
Time Frame
baseline and immediately after the intervention
Title
Change in Montreal Cognitive Assessment (MoCA) Score
Description
We adopted a localized version of MoCA in line with the Chinese cultural background. It includes 11 inspection items in 8 cognitive fields. With a total score of 30 or more than 26, it is normal. Anyone who has been educated for less than 12 years will need to add one point to his final score. A higher score indicates a better outcome.
Time Frame
baseline and immediately after the intervention
Title
Change in Auditory Verbal Learning Test (AVLT) Score
Description
We adopted a localized version of AVLT in line with the Chinese cultural background. It includes a 5-trial presentation of a 15-word list (List A), a single presentation of an interference list (List B)(Trial 6), two post-interference recall trials (one immediate - Trial 7, one delayed - Trial 8) and recognition of the target words in the orthographic modality with distractors (Trial 9). Scoring includes the percent score of the mean of Trial 1 through 5, Trial 7, Trial 8 and Trial 9. A higher score indicates a better outcome.
Time Frame
baseline and immediately after the intervention
Title
EEG Measure of Frontal Alpha Asymmetry (FFA) Oscillations
Description
EEG recordings were obtained from each subject based on 64 electrode locations of the International 10-20 system (sampling frequency 1000Hz). The change in FFA (8-13 Hz electrical activity) over time was measured.
Time Frame
baseline and immediately after the intervention
Title
MRI measures of functional connectivity (FC)
Description
the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.
Time Frame
baseline and immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 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 65 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Wang, PhD
Phone
+86055162923704
Email
wangkai1964@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanghua Tian, PhD
Phone
+86055162923704
Email
ayfytyh@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanghua Tian, PhD
Organizational Affiliation
Anhui Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Yanghua Tian
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanghua Tian, PhD
Phone
+86055162923704
Email
ayfytyh@126.com

12. IPD Sharing Statement

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Intervention Effect of High Definition Transcranial Alternating Current Stimulation (HD-tACS) on Depressive Disorder

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