Meditation Accelerated Brain Stimulation for Depression

Depression Clinical Trial

— MediTMS  

Official title:

Meditation Accelerated Brain Stimulation for Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586699
• Other study ID #: MediTMS
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: July 15, 2025

Study information

• Verified date: August 2023
• Source: University of California, San Diego
• Contact: Jyoti Mishra, PhD
• Phone: (858) 822-0568
• Email: jymishra[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 15, 2025
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Medi1TMS
rTMS theta-burst protocol paired with a consistent attention-to-breath task
• Medi2TMS
rTMS theta-burst protocol paired with an intermittent deep breathing task

Locations

Country	Name	City	State
United States	Neuromodulation Clinic Veterans Affairs San Diego	San Diego	California
United States	UC San Diego Health Psychiatry	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

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