Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Treatment for Major Depressive Episode
NCT05498441 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2023-10-18
Summary
Adolescents with mood disorders experiencing major depressive episode have poor efficacy of medication treatment. High-Definition Transcranial Direct Current Stimulation (HD-tDCS) has been proven adjuvant efficacy in patients with major depressive episode. However, the optimal evidence-based stimulation parameters have not been clearly defined, which greatly limits the efficacy of HD-tDCS in the treatment of major depressive episode.This trial will compare a novel form of accurate and personalized HD-tDCS treatment protocol guided by neuroimaging biomarkers to the routine stimulation(stimulation target is L-DLPFC, central electrode is anode).The personalized selection of stimulation site, central electrode polarity will be determined by neuroimaging biomarkers. The study aims to propose a novel personalized neuroimaging-guided HD-tDCS strategy, to evaluate the efficacy and safety of the treatment, further to understand the biological mechanism of the personalized HD-tDCS treatment.
Conditions
- Major Depressive Episode
Interventions
- DEVICE
-
High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
High-Definition Transcranial Direct Current Stimulation (HD-tDCS) is a non-invasive neuromodulation therapy which has been recognized as a helpful treatment for depression. During each HD-tDCS treatment, the electrode field is generated by a 4\*1 ring montage which is placed over the scalp on the brain region of interest with an electrical current induced to modulate brain activity.
- DRUG
-
Antipsychotics, mood stabilizers, etc.
During the HD-tDCS treatment period, all the participants will maintain the stable medication regimen according to clinical practice guidelines.
Sponsors & Collaborators
-
Jiangsu Province Nanjing Brain Hospital
lead OTHER
Principal Investigators
-
Fei Wang · Affiliated Nanjing Brain Hospital, Nanjing Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-01
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- China
Study Locations
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