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Meditation Accelerated Brain Stimulation for Depression (MediTMS)

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ClinicalTrials.gov Identifier: NCT04586699
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Jyoti Mishra, University of California, San Diego

Study Description
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Brief Summary:
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from ~15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention.

Condition or disease Intervention/treatment Phase
Depression Device: Medi1TMS Device: Medi2TMS Not Applicable

Detailed Description:
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from ~15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention. Meditative internal focus has been shown to benefit depression. Our own research shows that the neural correlates of attention-to-breath are associated with greater mindfulness. Hence, in this study we will pair breath training with rTMS neuro-stimulation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Meditation Accelerated Brain Stimulation for Depression
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : July 15, 2024
Estimated Study Completion Date : July 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Medi1TMS
rTMS theta-burst protocol paired with a consistent attention-to-breath task
 Device: Medi1TMS
rTMS theta-burst protocol paired with a consistent attention-to-breath task
Active Comparator: Medi2TMS
rTMS theta-burst protocol paired with an intermittent deep breathing task
 Device: Medi2TMS
rTMS theta-burst protocol paired with an intermittent deep breathing task


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline Clinical Depression [ Time Frame: up to 6 weeks ]
    PHQ9 depression scale

  2. Change from baseline brain activity in attention-to-breath task [ Time Frame: up to 6 weeks ]
    Electroencephalography (EEG) power in theta-alpha band in attention-to-breath task


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate to severe depression (PHQ-9 scale score >9 with confirmation using the Structured Clinical Interview for DSM-5 Disorders)
  • treatment refractory to antidepressants (i.e. failed 1-3 antidepressants in current episode) or intolerant to antidepressants (i.e. tried 2 antidepressant of inadequate dose/duration in current episode)

Exclusion Criteria:

  • active substance abuse/dependence
  • psychotic disorders
  • any factor that increases risk of TMS (metal implants/history of stroke/seizure disorder).
  • displaying acutely suicidal behaviors on the Columbia Suicide Severity Rating Scale.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586699


Contacts
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Contact: Jyoti Mishra, PhD (858) 822-0568 jymishra@ucsd.edu
Contact: Dhakshin Ramanathan, MDPhD (858) 822-0568 dramanathan@ucsd.edu

Locations
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United States, California
Neuromodulation Clinic Veterans Affairs San Diego Recruiting
San Diego, California, United States, 92037
Contact: Dhakshin Ramanathan, MDPhD       dramanathan@ucsd.edu   
UC San Diego Health Psychiatry Recruiting
San Diego, California, United States, 92127
Contact: Jyoti Mishra, PhD    858-822-0568    jymishra@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Jyoti Mishra, PhD University of California, San Diego
More Information
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Responsible Party: Jyoti Mishra, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04586699    
Other Study ID Numbers: MediTMS
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified raw and processed data will be shared with other researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: At time of publication
Access Criteria: The PI will review sharing requests and provide access to researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders