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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06529341
Enrollment
60
Registered
2024-07-31
Start date
2024-07-30
Completion date
2025-12-30
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, High-definition Transcranial Direct Current Stimulation

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.

Interventions

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)

OTHERHigh-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.

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Hamilton Anxiety Scale1 weekHAMA 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.

Countries

China

Contacts

Primary ContactChun Wang
fm51109@163.com+8615850566376

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026