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

Official title

Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation for Depression Based on Individualized Functional Connectivity Localization of Orbital Frontal Cortex-habenula

Overview

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

Interventions

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

Primary outcome measures

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10 [Time frame: Baseline and treatment day 10]

Secondary outcome measures (9)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 28 days after the end of treatment [Time frame: Baseline and 28 days after the end of treatment]
• Change in Hamilton Anxiety Scale scores from baseline to treatment day 10 [Time frame: Baseline and treatment day 10]
• Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment [Time frame: Baseline and 28 days after the end of treatment]
• Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 10 [Time frame: Baseline and treatment day 10]
• Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment [Time frame: Baseline and 28 days after the end of treatment]
• Change in Pittsburgh sleep quality index (PSQI) scores from baseline to treatment day 10 [Time frame: Baseline and treatment day 10]
• Change in Pittsburgh sleep quality index (PSQI) scores from baseline to 28 days after the end of treatment [Time frame: Baseline and 28 days after the end of treatment]
• Change in Snaith-Hamilton Pleasure Scale scores from baseline to treatment day 10 [Time frame: Baseline and treatment day 10]
• Change in Snaith-Hamilton Pleasure Scale scores from baseline to 28 days after the end of treatment [Time frame: Baseline and 28 days after the end of treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Xijing Hospital — Xi'an

Publications

• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06837207 · KY20242429

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗