Meditation Accelerated Brain Stimulation for Depression (MediTMS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression
• Intervention / Treatment: Device: Medi1TMS; Device: Medi2TMS

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92127
      • UC San Diego Health Psychiatry
    • San Diego, California, United States, 92037
      • Neuromodulation Clinic Veterans Affairs San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Clinical Depression (Remission)	PHQ9 depression scale	up to 6 weeks
Change from baseline brain activity in attention-to-breath task	Electroencephalography (EEG) power in attention-to-breath task	up to 6 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Jyoti Mishra, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): April 15, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: MediTMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified raw and processed data will be shared with other researchers.
• IPD Sharing Time Frame: At time of publication
• IPD Sharing Access Criteria: The PI will review sharing requests and provide access to researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• 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