Meditation Accelerated Brain Stimulation for Depression | NCT04586699

Studies
Meditation Accelerated Brain Stimulation for Depression

NCT04586699

Sponsor

University of California, San Diego

Status

Active, not recruiting

Last Update Posted

Dec 17, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Depression

Interventions

Medi1TMS
Medi2TMS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2021Actual

Primary Completion Date

Apr 15, 2025Actual

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Sep 30, 2020

First Submission Date that Met QC Criteria

Oct 8, 2020

First Posted Date

Oct 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2025

Last Update Posted Date

Dec 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jyoti Mishra, Assistant Professor, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Medi1TMS	Device	rTMS theta-burst protocol paired with a consistent attention-to-breath task	Medi1TMS

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jyoti Mishra, PhD	University of California, San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neuromodulation Clinic Veterans Affairs San Diego		San Diego	California	92037	United States
UC San Diego Health Psychiatry

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified raw and processed data will be shared with other researchers.

Types

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.

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Jan 26, 2025	Aug 1, 2025	ICF_000.pdf

Submission Tracking

Estimated Results First Submitted Date

Apr 14, 2026

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 14, 2026			May 4, 2026	16
May 8, 2026

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided