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

Not Applicable

Not yet recruiting

• Conditions: High-definition Transcranial Direct Current Stimulation; Anxiety Disorders
• Interventions: Other: High-definition transcranial direct current stimulation pseudo-stimulation control group; Other: High-definition transcranial direct current stimulation

• Registration Number: NCT06529341
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study Start: 2024-07-30
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-definition transcranial direct current stimulation pseudo-stimulation control group	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.
High-definition transcranial direct current stimulation	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)

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Scale	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.

Trial Locations

Locations (1)

Nanjing Brain Hospital; 🇨🇳 Nanjing, Jiangsu, China