Clinical trial NCT04586699: Meditation Accelerated Brain Stimulation for Depression
Official title: Meditation Accelerated Brain Stimulation for Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline Clinical Depression (Remission)
timeFrame: up to 6 weeks
measure: Change from baseline brain activity in attention-to-breath task
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Neuromodulation Clinic Veterans Affairs San Diego
state: California
city: San Diego
country: United States
facility: UC San Diego Health Psychiatry
state: California
Study officials:
affiliation: University of California, San Diego
name: Jyoti Mishra, PhD
role: PRINCIPAL_INVESTIGATOR
References: