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Mechanism and Efficacy Study of Acupuncture Combined with TMS Intervention on Cognitive Impairment in Adolescent MDD Based on Multimodal Brain Imaging and Blood Biomarkers

Mechanism and Efficacy Study of Acupuncture Combined with TMS Intervention on Cognitive Impairment in Adolescent MDD Based on Multimodal Brain Imaging and Blood Biomarkers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127896
Enrollment
Unknown
Registered
2026-07-09
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

major depressive disorder

Interventions

TMS Group:Before stimulation, three-dimensional T1-weighted structural magnetic resonance images of the subjects were collected, and the left dorsolateral prefrontal lobe (l-DLPFC) was located as the
A single treatment involves a total of 1,800 pulses, lasting approximately 10 minutes. Four treatments are carried out daily (a total of 7,200 pulses per day), with an interval of no less than one hou
Acupuncture-TMS Group:The operation of TMS is the same as above. Acupuncture points selected: Baihui, Shenting, bilateral Liver Shu, Spleen Shu, Kidney Shu, Hegu, Zusanli, Sanyinjiao, Taichong. Operat
Shenting: Insert 0.5 to 0.8 cun horizontally
Feishu: 0.5 to 0.8 cun of oblique puncture
Pishu: Insert 0.5 to 0.8 cun obliquely. Shenshu: Insert a direct puncture at 0.5 to 1.0 cun. Hegu: Insert 0.5 to 1.0 cun direc

Sponsors

Shandong Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
11 Years to 20 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for adolescent patients with depressive injury: (1) Diagnosed with major depressive disorder according to the criteria of the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the United States; (2) It meets the diagnostic criteria for "depression" in the "Diagnostic Efficacy Standards for Diseases and Syndromes in Traditional Chinese Medicine". (3) Age: 11 to 20 years old; (4) No intellectual impairment or other mental disorders, and able to cooperate in completing the relevant scales and cognitive tests of this study; (5) Obtain the consent of the patient and his/her legal guardian and have them sign the informed consent form. 2. Inclusion criteria for the control group: (1) Age: 11 to 20 years old; (2) After mental examination, there is no intellectual impairment and it does not meet any of the criteria for mental impairment as listed in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders of the United States; (3) No history of suicide or self-harm; (4) No history of substance dependence or alcohol or substance abuse; (5) Obtain the consent of the juvenile and his/her legal guardian and have them sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Contraindications for magnetic resonance imaging scans (e.g., claustrophobia, Meniere's syndrome; braces; history of brain surgery, brain trauma, and other serious systemic diseases; presence of pacemakers or artificial valves in the body; residual metal foreign bodies near vital organs, etc.); 2. Pre-existing or current neurological or intellectual impairments that may interfere with cognitive assessment; 3. History of neurological diseases and major somatic diseases; Those who co-suffer from other mental impairments, such as autism spectrum disorder, attention deficit hyperactivity disorder, tic disorder, etc. 4. Those with severe physical diseases.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale;

Secondary

MeasureTime frame
Hamilton Anxiety Rating Scale;Children's Depression Inventory;Somatic Symptom Disorder-B Criteria Scale;Patient Health Questionnaire-15;Structural MRI;Functional MRI;Arterial spin labeling perfusion imaging ;Diffusion Tensor Imaging;N-back Task;Stroop Color-Word Interference Task;Balloon Analog Risk Task;Stop-Signal Task;Wisconsin Card Sorting Test;Serum biomarkers such as BDNF, APLP1, HDAC3, FGF2, IL-6, and TNF-a;

Countries

China

Contacts

Public ContactYang Ying

Shandong Mental Health Center

doctoryy2022@163.com+86 139 6409 6176

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026