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

NCT ID: NCT06837207

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-03-01

Brief Summary

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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

Detailed Description

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Conditions

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Depression Transcranial Magnetic Stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individualized transcranial magnetic stimulation

Group Type EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type DEVICE

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

Interventions

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transcranial magnetic stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 .

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huaning Wang

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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yaochi Zhang

Role: CONTACT

18294037117

Facility Contacts

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zhao, PhD

Role: primary

18792536506

References

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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.

Reference Type BACKGROUND
PMID: 35026139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28886760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32800379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34482948 (View on PubMed)

Other Identifiers

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KY20242429

Identifier Type: -

Identifier Source: org_study_id

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