Meditation Accelerated Brain Stimulation for Depression

NCT04586699 | Active Not Recruiting FDA Device

• 1 other identifier: MediTMS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Medi1TMS

EXPERIMENTAL

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

Device: Medi1TMS

Medi2TMS

ACTIVE COMPARATOR

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

Device: Medi2TMS

Interventions

Medi1TMS DEVICE

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

Medi1TMS

Medi2TMS DEVICE

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

Medi2TMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

Neuromodulation Clinic Veterans Affairs San Diego

San Diego, California, 92037, United States

Location

UC San Diego Health Psychiatry

San Diego, California, 92127, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jyoti Mishra, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: July 15, 2021
• Primary Completion: April 15, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: At time of publication
• Access Criteria: The PI will review sharing requests and provide access to researchers.

Locations

US (2)