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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Disorders; High-definition Transcranial Direct Current Stimulation
• Intervention / Treatment: Other: High-definition transcranial direct current stimulation; Other: High-definition transcranial direct current stimulation pseudo-stimulation control group

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun Wang; Phone Number: +8615850566376; Email: fm51109@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210024
      • Nanjing Brain Hospital
      • Principal Investigator: Chun Wang
      • Contact: Jifan Wang; Phone Number: 8617766101293; Email: wangjfzds@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: 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)
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: July 6, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 123201004258009355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No