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Meditation Accelerated Brain Stimulation for Depression

NCT ID: NCT04586699

Last Updated: 2025-12-17

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Medi1TMS

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

Group Type EXPERIMENTAL

Medi1TMS

Intervention Type DEVICE

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

Medi2TMS

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

Group Type ACTIVE_COMPARATOR

Medi2TMS

Intervention Type DEVICE

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

Interventions

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Medi1TMS

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

Intervention Type DEVICE

Medi2TMS

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Jyoti Mishra

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jyoti Mishra, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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Neuromodulation Clinic Veterans Affairs San Diego

San Diego, California, United States

Site Status

UC San Diego Health Psychiatry

San Diego, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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MediTMS

Identifier Type: -

Identifier Source: org_study_id