NCT07184697Active, not recruiting
Efficacy and Safety of Task-specific, Biomarker-driven, HD-ctACS inTRD.
Efficacy and Safety of Task-specific, Biomarker-driven, High-definition, Closed-loop Transcranial Alternating Current Stimulation (HD-ctACS) in Treatment-Resistant Depression (TRD): A Randomized, Double-blind, Sham-controlled, Crossover Trial.
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
This is a single-center, randomized, double-blind, sham-controlled, crossover exploratory clinical trial designed to evaluate the therapeutic effects of task-specific, biomarker-driven HD-ctACS on treatment-resistant depression (TRD). The study will enroll 10 patients diagnosed with TRD. Each participant will, in a randomized order, undergo a 4-week active HD-ctACS treatment period and a 4-week sham stimulation (delayed HD-ctACS) period, separated by an 8-week washout period. The primary objective is to assess the efficacy of HD-ctACS in improving core depressive symptoms, with the primary outcome being the difference in the Hamilton Depression Rating Scale (HAMD) total score between the end of the two intervention periods. Secondary objectives include evaluating the safety of the therapy, its effects on other symptom dimensions, and exploring its modulatory effects on neurobiological markers of emotional processing (e.g., NAc gamma power). The total participation time for each subject is approximately 16 weeks.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 4 Sept 2025
- Start date
- 14 Aug 2025
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Ruijin Hospital
- Diseases
- Depression
- NCT number
- NCT07184697
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 14 Aug 2025 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of alcohol or substance abuse/dependence (within the last year).
- History of epilepsy or has intracranial metal implants (other than the research electrodes).
- Presence of any unstable and significant somatic illness.
Other
- Current severe suicide risk.
- Women who are pregnant or breastfeeding.
- Currently participating in another clinical trial.
Who the study is looking for
- Meets DSM-5 diagnostic criteria for Major Depressive Disorder (MDD), currently in a moderate to severe episode (total HAMD score ≥ 17).
- Meets the definition of Treatment-Resistant Depression (TRD): failure to respond to or intolerance of at least two antidepressant medications from different mechanistic classes, administered at an adequate dose and duration (e.g., 6-8 weeks) during the current depressive episode.
- Agrees to maintain a stable dosage of their current antidepressant medication regimen (if taking any) throughout the study period.
- Able to comprehend the study procedures and voluntarily provide written informed consent.
- Has intracranial deep brain electrodes implanted for research purposes, with electrodes located in the target brain regions (e.g., NAc, BNST).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.