Meditation Accelerated Brain Stimulation for Depression

Not Applicable

Active, not recruiting

• Conditions: Depression
• Interventions: Device: Medi2TMS; Device: Medi1TMS

• Registration Number: NCT04586699
• Lead Sponsor: University of California, San Diego

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

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 Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-14
• Study Start: 2021-07-15
• Primary Completion: 2025-04-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medi2TMS	Medi2TMS	rTMS theta-burst protocol paired with an intermittent deep breathing task
Medi1TMS	Medi1TMS	rTMS theta-burst protocol paired with a consistent attention-to-breath task

Primary Outcome Measures

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

Trial Locations

Locations (2)

Neuromodulation Clinic Veterans Affairs San Diego; 🇺🇸 San Diego, California, United States

UC San Diego Health Psychiatry; 🇺🇸 San Diego, California, United States