Transcranial Direct Current StimulationNCT05298007
Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Anxiety Disorder
A study testing High definition transcranial direct current stimulation in people with Transcranial Direct Current Stimulation and Anxiety, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying neural mechanism by MRI. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Anxiety, Magnetic Resonance Imaging
- What is being tested?
- High definition transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei
YangHua Tian, PhD, +8613955188448, ayfytyh@126.com
Ting Zhang, +8618356050012, zhangting9306@163.com
About this study
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying neural mechanism by MRI.
Read the 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.
- Being tested
- High definition transcranial direct current stimulation, sham high definition transcranial direct current stimulation
- Keywords
- Transcranial Direct Current Stimulation, Anxiety, Magnetic Resonance Imaging
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition transcranial direct current stimulationDevice
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 high definition transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| real stimulation | Active comparator | 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. Receives: Device: High definition transcranial direct current stimulation |
| sham stimulation | Sham comparator | 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. Receives: Device: sham high definition transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 dDCS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
Measured: baseline and immediately after intervention
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.
Measured: baseline and immediately after intervention
Secondary outcomes (5)
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.
Measured: baseline and immediately after intervention
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.
Measured: baseline and immediately after intervention
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.
Measured: baseline and immediately after intervention
4DSQ-Som(Four-DimensionalSymptomQuestionnaire)
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
Measured: baseline and immediately after intervention
HAMD(Hamilton Depression Scale)
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.
Measured: baseline and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Jan 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- More trials run by Anhui Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
- Investigators
- Ting Zhang, Study chair, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298007
- Sponsor's protocol ID
- ahmu-tdcs-anxiety
- Status last verified
- Mar 2022
- First submitted
- 13 Feb 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05298007
- Acronym / sponsor ID
- ahmu-tdcs-anxiety
- Keywords
- Transcranial Direct Current Stimulation, Anxiety, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying neural mechanism by MRI.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real stimulation | Active comparator | Device: High definition transcranial direct current stimulationParticipants 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. |
| sham stimulation | Sham comparator | Device: sham high definition transcranial direct current stimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High definition transcranial direct current stimulationtDCS 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. | Device | real stimulation |
| sham high definition transcranial direct current stimulationSham 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. | Device | sham stimulation |
Primary outcome
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
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.
5 secondary outcomes
somatic symptoms
Time frame: baseline and immediately after intervention
ISI(The insomnia severity index)
Time frame: baseline and immediately after intervention
SAS(Self-rating anxiety scale)
Time frame: baseline and immediately after intervention
4DSQ-Som(Four-DimensionalSymptomQuestionnaire)
Time frame: baseline and immediately after intervention
HAMD(Hamilton Depression Scale)
Time frame: baseline and immediately after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Zhang study chair
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High definition transcranial direct current stimulation in people with Transcranial Direct Current Stimulation and Anxiety, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, PhD (+86-0551-62923704, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety symptoms (time frame: baseline and immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.