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

NCT06529341 | Not Yet Recruiting

• 1 other identifier: 123201004258009355
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Study Arms (2)

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)

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.

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

Interventions

High-definition transcranial direct current stimulation 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

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

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

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, 210024, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Chun Wang

CONTACT

+8615850566376; fm51109@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 31, 2024
• Study Start: July 30, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)