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Active, Not Recruiting

NCT Number: NCT04586699

Meditation Accelerated Brain Stimulation for Depression

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuromodulation Clinic Veterans Affairs San Diego, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medi1TMS

Device

rTMS theta-burst protocol paired with a consistent attention-to-breath task

Medi2TMS

Device

rTMS theta-burst protocol paired with an intermittent deep breathing task

Primary outcomes

  1. Change from baseline Clinical Depression (Remission)

    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 attention-to-breath task

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: MediTMS

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Oct 14, 2020
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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