rTMS Response Trajectories in Depression

NCT03348761 | Recruiting DMC

• 1 other identifier: CRE-2014.041
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Notwithstanding the cumulative evidence on the safety and efficacy of transcranial magnetic stimulation in depression care, the non-response rate to transcranial magnetic stimulation (TMS) amongst treatment-resistant depression has remained substantial despite the health care cost and time incurred. There remains a compelling clinical need to find valid biomarkers to inform personalized treatment. Using supervised machine learning on 4 combined features of neuroimaging markers, our group recently reported excellent prediction for clinical response in 70 patients receiving TMS to left dorsolateral prefrontal cortex for medication-resistant major depression in 2015-18 (Phase 1 study).The clinical utility of these potential neuroimaging biomarkers is still uncertain without further validation of the trained model in an independent clinical cohort.

Conditions

Depression

Keywords

Repetitive Transcranial Magnetic Stimulation; resting-state Functional magnetic resonance imaging; treatment response; neurostimulation; dorsolateral prefrontal cortex; subgenual anterior cingulate cortex

Outcome Measures

Primary Outcomes (4)

• Montgomery-Ashberg Depression Rating Scale

  Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.

  Percentage change baseline versus week 4

• Montgomery-Ashberg Depression Rating Scale

  Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.

  Percentage change baseline versus week 6

• Montgomery-Ashberg Depression Rating Scale

  Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.

  Percentage change baseline versus week 8

• Montgomery-Ashberg Depression Rating Scale

  Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.

  Percentage change baseline versus week 12

Secondary Outcomes (4)

• Clinical Global Impression Scale

  Percentage change baseline versus week 4

• Clinical Global Impression Scale

  Percentage change baseline versus week 6

• Clinical Global Impression Scale

  Percentage change baseline versus week 8

• Clinical Global Impression Scale

  Percentage change baseline versus week 12

Study Arms (1)

rTMS Group

EXPERIMENTAL

Phase I: A Magstim Super-Rapid device with a 70-mm figure-of-eight double air film coil (Magstim Ltd, UK) and Brainsight neuronavigation (Rogue Resolutions Ltd, Canada) are used. Stimulation parameters: 10 Hz, 120% resting motor threshold, 30 trains of 5 seconds with 25 seconds rest, 3000 pulses per day delivered 5 days per week (total: 60000 pulses). Phase II: MagVita X100 (FDA approved device) will be used to deliver intermittent theta burst stimulation (iTBS) to left DLPFC, comprising of 18 cycles of 10 bursts. Each burst is triplet of pulses discharged at 50 hz and the burst frequency is 5Hz. Between two cycles of bursts is 8-second inter-train rest. The device output is set at 120% above the resting motor threshold

Device: rTMS group

Interventions

rTMS group DEVICE

rTMS Group

Eligibility Criteria

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

You may qualify if:

• right-handed
• meet the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) criteria for major depressive disorder
• at least moderate episode or with a score of \>20 on Montgomery-asberg Depression Rating Scale (MADRS) and \>18 on Hamilton Depression Rating Scale(HDRS) 17-item;
• has failed to respond adequately to at least one full course (\>6 weeks) of antidepressant medication or medication intolerant.

You may not qualify if:

• significant head trauma
• active abuse of alcohol or illegal substances
• current psychotic symptoms
• suicide ideation/recent suicide attempts
• other DSM-IV Axis I and II psychiatric diagnosis
• neurological disorders and contraindications to fMRI (e.g. pace makers, metal implants, pregnancy) or rTMS, or having undergone electroconvulsive therapy in the preceding year.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, CUHK

Hong Kong, 852, Hong Kong

RECRUITING

Related Publications (14)

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  PMID: 444788 BACKGROUND

• HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.

  PMID: 14399272 BACKGROUND

• So E, Kam I, Leung CM, Chung D, Liu Z, Fong S. The Chinese-Bilingual SCID-I/P Project: stage 1- reliability for mood disorders and schizophrenia. East Asian Archives of Psychiatry 2003; 13: 7-18.

  BACKGROUND

• Wong HM, Chow LY. Borderline personality disorder subscale (Chinese version) of the structured clinical interview for DSM-IV axis II personality disorders: a validation study in Cantonese-speaking Hong Kong Chinese. East Asian Arch Psychiatry. 2011 Jun;21(2):52-7.

  PMID: 21838207 BACKGROUND

• Ballenger JC. Clinical guidelines for establishing remission in patients with depression and anxiety. J Clin Psychiatry. 1999;60 Suppl 22:29-34.

  PMID: 10634353 BACKGROUND

• Beck A, Steer R, Brown G. RCMAR Measurement Tools Beck Depression Inventory - 2nd Edition (BDI-II). The Psychological Corporation, San Antonio 1996.

  BACKGROUND

• Wu PC, Chang L. Psychometric Properties of the Chinese Version of the Beck Depression Inventory-II Using the Rasch Model. Measurement & Evaluation in Counseling & Development 2008; 41:13-31.

  BACKGROUND

• Trull TJ, Geary DC. Comparison of the big-five factor structure across samples of Chinese and American adults. J Pers Assess. 1997 Oct;69(2):324-41. doi: 10.1207/s15327752jpa6902_6.

  PMID: 9392894 BACKGROUND

• Lo CS, Ho SM, Hollon SD. The effects of rumination and negative cognitive styles on depression: a mediation analysis. Behav Res Ther. 2008 Apr;46(4):487-95. doi: 10.1016/j.brat.2008.01.013. Epub 2008 Jan 30.

  PMID: 18316063 BACKGROUND

• Robinson LA, Alloy LB. Negative cognitive styles and stress-reactive rumination interact to predict depression: a prospective study. Cognitive therapy and research 2003; 27: 275-292.

  BACKGROUND

• Murphy K, Fox MD. Towards a consensus regarding global signal regression for resting state functional connectivity MRI. Neuroimage. 2017 Jul 1;154:169-173. doi: 10.1016/j.neuroimage.2016.11.052. Epub 2016 Nov 22.

  PMID: 27888059 BACKGROUND

• Behzadi Y, Restom K, Liau J, Liu TT. A component based noise correction method (CompCor) for BOLD and perfusion based fMRI. Neuroimage. 2007 Aug 1;37(1):90-101. doi: 10.1016/j.neuroimage.2007.04.042. Epub 2007 May 3.

  PMID: 17560126 BACKGROUND

• Whitfield-Gabrieli S, Nieto-Castanon A. Conn: a functional connectivity toolbox for correlated and anticorrelated brain networks. Brain Connect. 2012;2(3):125-41. doi: 10.1089/brain.2012.0073. Epub 2012 Jul 19.

  PMID: 22642651 BACKGROUND

• Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. Biol Psychiatry. 2012 Oct 1;72(7):595-603. doi: 10.1016/j.biopsych.2012.04.028. Epub 2012 Jun 1.

  PMID: 22658708 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Sau Man S Chan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Department of Psychiatry

CONTACT

852-2607-6027; psychiatry@cuhk.edu.hk

Helene J Hopman

CONTACT

852-5597-1622; hjhopman@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants receive a 4-week repetitive transcranial magnetic stimulation to the left dorolateral prefrontal cortex with pre-treatment resting state MRI Brain taken, that will be subsequently used to model the clinical outcome prediction taking into account other biomarkers.

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 21, 2017
• Study Start: August 4, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)