- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05298007
Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Anxiety Disorder
Study Overview
Status
Detailed Description
Anxiety is characterized by excessive fear, anxiety, or avoidance of a range of external and internal stimuli. Somatic symptoms often co-occur with anxiety and are part of the manifestation of anxiety. The purpose of this study was to explore the relieving effect of high definition transcranial direct current stimulation (HD-tDCS) on the symptoms of anxiety.
60 patients with anxiety 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kai Wang, PhD
- Phone Number: +86-0551-62923704
- Email: wangkai1964@126.com
Study Contact Backup
- Name: Yanghua Tian, PhD
- Phone Number: +8613955188448
- Email: ayfytyh@126.com
Study Locations
-
-
-
Hefei, China
- Recruiting
- Anhui Medical University
-
Contact:
- Yanghua Tian, PhD
- Phone Number: +8613955188448
- Email: ayfytyh@126.com
-
Contact:
- Ting Zhang
- Phone Number: +8618356050012
- Email: zhangting9306@163.com
-
Principal Investigator:
- Qiangqiang Hou
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: real stimulation
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.
Fourteen2-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.
|
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.
|
Sham Comparator: sham stimulation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
resting-state functional connectivity
Time Frame: baseline and immediately after intervention
|
the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.
|
baseline and immediately after intervention
|
anxiety symptoms
Time Frame: baseline and immediately after intervention
|
the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to dDCS.
HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
|
baseline and immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
somatic symptoms
Time Frame: baseline and immediately after intervention
|
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.
|
baseline and immediately after intervention
|
ISI(The insomnia severity index)
Time Frame: baseline and immediately after intervention
|
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.
|
baseline and immediately after intervention
|
SAS(Self-rating anxiety scale)
Time Frame: baseline and immediately after intervention
|
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.
|
baseline and immediately after intervention
|
4DSQ-Som(Four-DimensionalSymptomQuestionnaire)
Time Frame: baseline and immediately after intervention
|
The Four-DimensionalSymptomQuestionnaire (4DSQ) includes self-rating scale for depression, anxiety and somatization.
In this experiment, only part of the somatization scale was used to evaluate the change of severity of patients' somatization symptoms.
Patients need to check the frequency of 15 symptoms, the higher the score, the more severe the symptoms.
4DSQ-Som scale scores range from 0 to 60 points
|
baseline and immediately after intervention
|
HAMD(Hamilton Depression Scale)
Time Frame: baseline and immediately after intervention
|
Anxiety patients are often complicated with depressive symptoms.The changes of depressive symptoms will assessed by HAMD, constituting the secondary research outcome.
Hamilton Depression Scale (HAMD) compiled by Hamilton in 1960, is the most common clinical to assess Depression Scale.
In this study, 17 versions were selected, and there were 17 questions.
The subjects were assessed for their depression in the past week.
Each question scored between 0 and 4 points.HAMD scale scores range from 0 to 54 points.
Higher scores indicate more depressive symptoms.
|
baseline and immediately after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ting Zhang, Anhui Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ahmu-tdcs-anxiety
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Queen's UniversityActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on High definition transcranial direct current stimulation
-
The University of Texas at DallasUniversity of Texas Southwestern Medical CenterRecruitingMemory Disorders | Word Finding DifficultyUnited States
-
Anhui Medical UniversityRecruitingDepressive Disorder | Functional Magnetic Resonance Imaging | Transcranial Direct Current StimulationChina
-
University of Texas Rio Grande ValleyRecruitingSpinal Cord Diseases | Spinal Cord InjuriesUnited States
-
Anhui Medical UniversityRecruitingTranscranial Magnetic Stimulation | Functional Magnetic Resonance Imaging | Refractory Epilepsy | Transcranial Direct Current Stimulation | EEGChina
-
University of TehranRecruitingHealthy VolunteersIran, Islamic Republic of
-
Anhui Medical UniversityRecruitingTranscranial Direct Current Stimulation | Non Suicidal Self InjuryChina
-
Carle Foundation HospitalAmerican Heart AssociationRecruiting
-
University of Texas Southwestern Medical CenterRecruitingMild Cognitive Impairment | Mild Traumatic Brain Injury | Amnestic Mild Cognitive Impairment | Concussion, Brain | Amnestic Mild Cognitive DisorderUnited States
-
University of OklahomaOklahoma Shared Clinical and Translational ResourcesRecruiting
-
University of ManitobaParkinson Society CanadaRecruitingParkinson Disease | Mild Cognitive ImpairmentCanada