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NCT Number: NCT06529341

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

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.

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Key information

Conditions

Anxiety Disorders High-definition Transcranial Direct Current Stimulation Mental Disorders

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Brain Hospital

Nanjing, Jiangsu, 210024, China

Location contact

Chun Wang

PRINCIPAL_INVESTIGATOR

Jifan Wang

CONTACT

[email protected]

8617766101293

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.

Treatment and study plan

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 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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chun Wang

CONTACT

[email protected]

+8615850566376

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 31, 2024
Registry last updated: Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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