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Intervention Effect of Transcranial Alternating Current Stimulation(tACS) on Anxiety Disorder

Primary Purpose

Transcranial Alternating Current Stimulation, Anxiety Disorder, Magnetic Resonance Imaging

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcranial alternating current stimulation
sham 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 focused on measuring Transcranial Alternating Current Stimulation, Anxiety Disorder, Magnetic Resonance Imaging

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 anxiety, and HAMA>14, 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 experiments, 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

Sham Comparator

Arm Label

real stimulation

sham stimulation

Arm Description

Participants will receive active tACS twice daily for one week. The anode was placed over AF3 with return electrodes placed at the contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as 8 Hz.

Participants will receive sham tACS twice daily for one week. Sham 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 30 and 30 seconds.

Outcomes

Primary Outcome Measures

anxiety symptoms
the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
resting-state functional connectivity
the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.

Secondary Outcome Measures

somatic symptoms
the change of somatic symptoms will be assessed by Patient Health Questionnaire (PHQ-15). PHQ-15 is composed of 15 physical symptoms that have been extracted from the PHQ. PHQ-15 scale scores range from 0 to 30 points. Higher scores indicate more severe somatic symptoms.
SAS(Self-rating anxiety scale)
Self-rating anxiety scale(SAS) is a supplementary evaluation of the change of anxiety state of patients in this experiment, and it also belongs to the category of self-rating scale. Patients assessed anxiety by checking the frequency of 20 items: none or almost none, sometimes, most of the time, most of the time, or all of the time. SAS scale scores range from 0 to 100 points。The higher the score, the more serious the anxiety symptoms.
ISI(The insomnia severity index)
ISI(The insomnia severity index) is used to evaluate the changes of sleep status of anxiety patients in the recent (2 weeks), which is a self-rating scale. ISI scale scores range from 0 to 28 points. The higher the score is, the worse the sleep quality is. This scale indirectly reflects the changes of patients' anxiety state through evaluation.

Full Information

First Posted
August 31, 2023
Last Updated
October 13, 2023
Sponsor
Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06026826
Brief Title
Intervention Effect of Transcranial Alternating Current Stimulation(tACS) on Anxiety Disorder
Official Title
Intervention Effect of Transcranial Alternating Current Stimulation(tACS) on Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 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

5. Study Description

Brief Summary
To investigate the intervention effect of transcranial alternating current stimulation(tACS) on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying neural mechanism by MRI.
Detailed Description
Forty patients with anxiety disorder diagnosed by DSM-5 were recruited from the second affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving tACS. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and tACS 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 AF3 with return electrodes placed at the contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as 8 Hz. Sham 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 30 and 30 seconds. Before and after the tACS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included HAMD, HAMA, PHQ15, ISI, ASI, SAS, RRS, IUS. Multimodal fMRI includes 3D-T1, rs-fMRI and DTI. 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 Alternating Current Stimulation, Anxiety Disorder, Magnetic Resonance Imaging
Keywords
Transcranial Alternating Current Stimulation, Anxiety Disorder, Magnetic Resonance Imaging

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
Participants will receive active tACS twice daily for one week. The anode was placed over AF3 with return electrodes placed at the contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as 8 Hz.
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
Participants will receive sham tACS twice daily for one week. Sham 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 30 and 30 seconds.
Intervention Type
Device
Intervention Name(s)
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 transcranial alternating current stimulation
Intervention Description
Sham 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 30 and 30 seconds.
Primary Outcome Measure Information:
Title
anxiety symptoms
Description
the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
Time Frame
baseline and immediately after intervention
Title
resting-state functional connectivity
Description
the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.
Time Frame
baseline and immediately after intervention
Secondary Outcome Measure Information:
Title
somatic symptoms
Description
the change of somatic symptoms will be assessed by Patient Health Questionnaire (PHQ-15). PHQ-15 is composed of 15 physical symptoms that have been extracted from the PHQ. PHQ-15 scale scores range from 0 to 30 points. Higher scores indicate more severe somatic symptoms.
Time Frame
baseline and immediately after intervention
Title
SAS(Self-rating anxiety scale)
Description
Self-rating anxiety scale(SAS) is a supplementary evaluation of the change of anxiety state of patients in this experiment, and it also belongs to the category of self-rating scale. Patients assessed anxiety by checking the frequency of 20 items: none or almost none, sometimes, most of the time, most of the time, or all of the time. SAS scale scores range from 0 to 100 points。The higher the score, the more serious the anxiety symptoms.
Time Frame
baseline and immediately after intervention
Title
ISI(The insomnia severity index)
Description
ISI(The insomnia severity index) is used to evaluate the changes of sleep status of anxiety patients in the recent (2 weeks), which is a self-rating scale. ISI scale scores range from 0 to 28 points. The higher the score is, the worse the sleep quality is. This scale indirectly reflects the changes of patients' anxiety state through evaluation.
Time Frame
baseline and immediately after 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 anxiety, and HAMA>14, 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 experiments, such as patients with depressive stupor, claustrophobia and so on.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Kai, PhD
Phone
+86-0551-62923704
Email
wangkai1964@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tongjian Bai
Phone
+8615256972606
Email
baiyunong1990@163.com
Facility Information:
Facility Name
Anhui Medical University
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongjian Bai
Email
ahmubtj1990@126.com

12. IPD Sharing Statement

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