Anxiety DisordersNCT06529341
Efficacy of High-precision Transcranial Direct Current Stimulation on Anxiety Disorders
A study testing High-definition transcranial direct current stimulation in people with Anxiety Disorders and High-definition Transcranial Direct Current Stimulation, run by Nanjing Medical University at 1 site in China.
Trial summary
1. Current research has found that tDCS has a positive effect on improving the negative attention bias of AD patients, and this study uses HD-tDCS intervention to improve the cognitive function and neural mechanisms of AD patients in the OFC to provide a theoretical basis for AD neural mechanism research. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, High-definition Transcranial Direct Current Stimulation
- What is being tested?
- High-definition transcranial direct current stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meet the DSM-5 AD diagnostic criteria;
- The Chinese version of the Brief International Neuropsychiatric Interview (MINI) screening meets the diagnosis;
- Age: 18-55 years old;
- The patient participated voluntarily, obtained the consent of the family members, and signed the informed consent form;
- Scale score criteria: 14 points on the Hamilton Anxiety Scale (HAMA) and 17 points on the Hamilton Depression Scale (HAMD).
Who cannot join
- Neurological diseases or other psychiatric disorders;
- severe somatic diseases;
- received medical treatment including medication, psychotherapy, electroconvulsive therapy, and physical therapy within the first half months of enrollment;
- tDCS examination contraindications, such as intracranial metal or electronic implants, skull plate, or other skull implants.
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Brain Hospital
Nanjing, Jiangsu, 210024
Jifan Wang, 8617766101293, wangjfzds@163.com
Chun Wang
About this study
- Current research has found that tDCS has a positive effect on improving the negative attention bias of AD patients, and this study uses HD-tDCS intervention to improve the cognitive function and neural mechanisms of AD patients in the OFC to provide a theoretical basis for AD neural mechanism research. Verify Hypothesis 1: HD-tDCS cathodal stimulation of the left OFC reduces the excitability of this region, modulates its connectivity with the attentional function network, and thus changes the emotional experience of social threat.
- Currently, there is no consensus on the stimulation parameters for tDCS in the treatment of AD, and more evidence is needed to prove and explore. It is hoped that the HD-tDCS intervention protocol will become an effective treatment method for improving cognitive function and clinical symptoms in AD patients. Hypothesis 2: The HD-tDCS with intensified stimulation parameters (2mA, twice a day, with a 20-minute interval, for 5 consecutive days) has an impact on the main and secondary clinical variables of AD patients.
- Being tested
- High-definition transcranial direct current stimulation, High-definition transcranial direct current stimulation pseudo-stimulation control group
- 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 stimulationOther
HD-tDCS stimulated AD left OFC (2 mA, 20 minutes, cathode electrode placed in the Fp 1 area, and the remaining four positive electrodes placed AF3, AF7, Afz, Fpz, forming a circular 41 focused electric field mode for stimulation, twice a day, 20 minutes interval for 5 days)
High-definition transcranial direct current stimulation pseudo-stimulation control groupOther
The treatment parameters of the electrode were the same as the test group, the stimulation current rose to the same 2 mA current in the test group within 30 seconds, and the pre-stimulation for 1 minute, then gradually to 0 mA.
| Study group | Role | What they receive |
|---|---|---|
| High-definition transcranial direct current stimulation | Experimental | HD-tDCS stimulated AD left OFC (2 mA, 20 minutes, cathode electrode placed in the Fp 1 area, and the remaining four positive electrodes placed AF3, AF7, Afz, Fpz, forming a circular 41 focused electric field mode for stimulation, twice a day, 20 minutes interval for 5 days) Receives: Other: High-definition transcranial direct current stimulation |
| High-definition transcranial direct current stimulation pseudo-stimulation control group | Active comparator | The treatment parameters of the electrode were the same as the test group, the stimulation current rose to the same 2 mA current in the test group within 30 seconds, and the pre-stimulation for 1 minute, then gradually to 0 mA. Receives: Other: High-definition transcranial direct current stimulation pseudo-stimulation control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Scale
HAMA was assessed at baseline and late 5 days after treatment by a professionally trained physician (non-trial intervention) to understand the effectiveness of treatment. Clinical efficacy evaluation criteria: 75% was recovered, 50% was significant, 25% was effective, and <25% was invalid.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion30 Jul 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 Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Nanjing 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Wang, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529341
- Sponsor's protocol ID
- 123201004258009355
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-precision Transcranial Direct Current Stimulation on Anxiety Disorders
- ClinicalTrials.gov ID
- NCT06529341
- Acronym / sponsor ID
- 123201004258009355
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 Jul 2024 (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.
- Current research has found that tDCS has a positive effect on improving the negative attention bias of AD patients, and this study uses HD-tDCS intervention to improve the cognitive function and neural mechanisms of AD patients in the OFC to provide a theoretical basis for AD neural mechanism research. Verify Hypothesis 1: HD-tDCS cathodal stimulation of the left OFC reduces the excitability of this region, modulates its connectivity with the attentional function network, and thus changes the emotional experience of social threat.
- Currently, there is no consensus on the stimulation parameters for tDCS in the treatment of AD, and more evidence is needed to prove and explore. It is hoped that the HD-tDCS intervention protocol will become an effective treatment method for improving cognitive function and clinical symptoms in AD patients. Hypothesis 2: The HD-tDCS with intensified stimulation parameters (2mA, twice a day, with a 20-minute interval, for 5 consecutive days) has an impact on the main and secondary clinical variables of AD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-definition transcranial direct current stimulation | Experimental | Other: High-definition transcranial direct current stimulationHD-tDCS stimulated AD left OFC (2 mA, 20 minutes, cathode electrode placed in the Fp 1 area, and the remaining four positive electrodes placed AF3, AF7, Afz, Fpz, forming a circular 41 focused electric field mode for stimulation, twice a day, 20 minutes interval for 5 days) |
| High-definition transcranial direct current stimulation pseudo-stimulation control group | Active comparator | Other: High-definition transcranial direct current stimulation pseudo-stimulation control groupThe treatment parameters of the electrode were the same as the test group, the stimulation current rose to the same 2 mA current in the test group within 30 seconds, and the pre-stimulation for 1 minute, then gradually to 0 mA. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Meet the DSM-5 AD diagnostic criteria;
- The Chinese version of the Brief International Neuropsychiatric Interview (MINI) screening meets the diagnosis;
- Age: 18-55 years old;
- The patient participated voluntarily, obtained the consent of the family members, and signed the informed consent form;
- Scale score criteria: 14 points on the Hamilton Anxiety Scale (HAMA) and 17 points on the Hamilton Depression Scale (HAMD).
Key exclusion criteria (5 listed)
- Neurological diseases or other psychiatric disorders;
- severe somatic diseases;
- received medical treatment including medication, psychotherapy, electroconvulsive therapy, and physical therapy within the first half months of enrollment;
- tDCS examination contraindications, such as intracranial metal or electronic implants, skull plate, or other skull implants.
- Pregnancy and lactation.
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 stimulationHD-tDCS stimulated AD left OFC (2 mA, 20 minutes, cathode electrode placed in the Fp 1 area, and the remaining four positive electrodes placed AF3, AF7, Afz, Fpz, forming a circular 41 focused electric field mode for stimulation, twice a day, 20 minutes interval for 5 days) | Other | High-definition transcranial direct current stimulation |
| High-definition transcranial direct current stimulation pseudo-stimulation control groupThe treatment parameters of the electrode were the same as the test group, the stimulation current rose to the same 2 mA current in the test group within 30 seconds, and the pre-stimulation for 1 minute, then gradually to 0 mA. | Other | High-definition transcranial direct current stimulation pseudo-stimulation control group |
Primary outcome
Hamilton Anxiety Scale
Time frame: 1 week
HAMA was assessed at baseline and late 5 days after treatment by a professionally trained physician (non-trial intervention) to understand the effectiveness of treatment. Clinical efficacy evaluation criteria: 75% was recovered, 50% was significant, 25% was effective, and <25% was invalid.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 Anxiety Disorders and High-definition Transcranial Direct Current Stimulation, run by Nanjing 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 5 inclusion and 5 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 31 Jul 2024. 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. 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 Chun Wang (+8615850566376, fm51109@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Scale (time frame: 1 week). 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 31 Jul 2024.