Precision Transcranial Magnetic Stimulation for Depression Based on Orbital Frontal Cortex-habenula Circuitry

NCT06837207 | Not Yet Recruiting

• 1 other identifier: KY20242429
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Thirty depressed patients will be recruited to select individualized transcranial magnetic stimulation targets based on individual orbital frontal cortex and habenula functional activity connectivity for 10 or 20 treatments to assess the efficacy and safety of this intervention

Conditions

Depression; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10

  The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used clinical assessment tool designed to measure the severity of depressive symptoms.The MADRS consists of 10 items, each of which addresses a different aspect of depression, such as low mood, loss of interest, sleep disorders, appetite, concentration, fatigue, inability to feel pleasure, pessimistic thinking, and suicidal ideation. Each item is scored according to the severity of symptoms, ranging from 0 to 6, with a total score ranging from 0-60, with higher scores indicating more severe depressive symptoms. Change = (treatment day 10 Score -Baseline Score).

  Baseline and treatment day 10

Secondary Outcomes (9)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 28 days after the end of treatment

  Baseline and 28 days after the end of treatment

• Change in Hamilton Anxiety Scale scores from baseline to treatment day 10

  Baseline and treatment day 10

• Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment

  Baseline and 28 days after the end of treatment

• Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 10

  Baseline and treatment day 10

• Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment

  Baseline and 28 days after the end of treatment

Study Arms (1)

Individualized transcranial magnetic stimulation

EXPERIMENTAL

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

Individualized transcranial magnetic stimulation of targets based on the association between the orbitofrontal cortex and the functional activity of the habenula .

Individualized transcranial magnetic stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gender is not limited, age 18～60 years old;
• Comply with the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) of the United States of America;
• Hamilton rating scale for depression (HAMD) 17-item score ≥ 18;
• The medication/psychotherapy received by the subject prior to the start of the study remained stable for at least 4 weeks .

You may not qualify if:

• History of serious somatic diseases or diseases that may affect the central nervous system (e.g., tumors, syphilis, etc.);
• Neurological disorders or risk of seizures, such as previous craniosynostosis, head trauma, alcoholism, abnormal electroencephalograms, MRI evidence of structural abnormalities in the brain, or family history of epilepsy;
• Patients with bipolar disorder and depression due to other psychiatric disorders (e.g., psychoactive and non-dependent substances);
• Contraindications to MRI scanning or transcranial magnetic stimulation therapy, such as metal or electronic devices placed in the body (intracranial metal foreign bodies, cochlear implants, pacemakers and stents and other metal foreign bodies), space phobia;
• People with psychotic symptoms requiring joint application of antipsychotic drugs;
• Those with high risk of suicide, or those who have already committed suicide or serious self-injury behavior requiring urgent intervention;
• Those who are pregnant, breastfeeding or planning to become pregnant during the trial;
• Other conditions judged by the investigator to be unsuitable as research subjects.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710000, China

Location

Related Publications (4)

• GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.

  PMID: 35026139 BACKGROUND

• Philip NS, Barredo J, van 't Wout-Frank M, Tyrka AR, Price LH, Carpenter LL. Network Mechanisms of Clinical Response to Transcranial Magnetic Stimulation in Posttraumatic Stress Disorder and Major Depressive Disorder. Biol Psychiatry. 2018 Feb 1;83(3):263-272. doi: 10.1016/j.biopsych.2017.07.021. Epub 2017 Aug 8.

  PMID: 28886760 BACKGROUND

• Cash RFH, Weigand A, Zalesky A, Siddiqi SH, Downar J, Fitzgerald PB, Fox MD. Using Brain Imaging to Improve Spatial Targeting of Transcranial Magnetic Stimulation for Depression. Biol Psychiatry. 2021 Nov 15;90(10):689-700. doi: 10.1016/j.biopsych.2020.05.033. Epub 2020 Jun 7.

  PMID: 32800379 BACKGROUND

• Goldstein-Piekarski AN, Ball TM, Samara Z, Staveland BR, Keller AS, Fleming SL, Grisanzio KA, Holt-Gosselin B, Stetz P, Ma J, Williams LM. Mapping Neural Circuit Biotypes to Symptoms and Behavioral Dimensions of Depression and Anxiety. Biol Psychiatry. 2022 Mar 15;91(6):561-571. doi: 10.1016/j.biopsych.2021.06.024. Epub 2021 Jul 11.

  PMID: 34482948 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Huaning Wang

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yaochi Zhang

CONTACT

18294037117; a18294037117@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: March 1, 2025
• Primary Completion: April 15, 2025
• Study Completion: March 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)