Efficacy of High-precision Transcranial Direct Current Stimulation on Anxiety Disorders

NCT ID: NCT06529341

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2025-12-30

Brief 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. 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.

2. 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.

Conditions

Anxiety Disorders; High-definition Transcranial Direct Current Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High-definition transcranial direct current stimulation

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)

Group Type: EXPERIMENTAL

High-definition transcranial direct current stimulation

Intervention Type: OTHER

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 group

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.

Group Type: ACTIVE_COMPARATOR

High-definition transcranial direct current stimulation pseudo-stimulation control group

Intervention Type: OTHER

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.

Interventions

High-definition transcranial direct current stimulation

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)

Intervention Type: OTHER

High-definition transcranial direct current stimulation pseudo-stimulation control group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Meet the DSM-5 AD diagnostic criteria;

2. The Chinese version of the Brief International Neuropsychiatric Interview (MINI) screening meets the diagnosis;

3. Age: 18-55 years old;

4. The patient participated voluntarily, obtained the consent of the family members, and signed the informed consent form;

5. Scale score criteria: 14 points on the Hamilton Anxiety Scale (HAMA) and 17 points on the Hamilton Depression Scale (HAMD).

Exclusion Criteria

1. Neurological diseases or other psychiatric disorders;

2. severe somatic diseases;

3. received medical treatment including medication, psychotherapy, electroconvulsive therapy, and physical therapy within the first half months of enrollment;

4. tDCS examination contraindications, such as intracranial metal or electronic implants, skull plate, or other skull implants.

5. Pregnancy and lactation.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chun Wang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Chun Wang

Role: CONTACT

fm51109@163.com

+8615850566376

Facility Contacts

Jifan Wang

Role: primary

wangjfzds@163.com

8617766101293

Other Identifiers

123201004258009355

Identifier Type: -

Identifier Source: org_study_id