Mindfulness Engaged Neurostimulation for Depression
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Change in EEG source localized pDMN alpha activity
Study Overview
Brief Summary
Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of ~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.
Detailed Description
This study aims to develop a novel multimodal treatment for treatment resistant depression (TRD), which combines intermittent theta burst stimulation (iTBS), a type of FDA-approved rTMS protocol, with digital mindfulness training. We propose that this multimodal treatment will suppress posterior Default Mode Network (pDMN) brain activity as measured with electroencephalography (primary outcome and neural target), as well as enhance cognition and alleviate depression symptoms in patients with TRD. The study will determine the optimal dose required for neural target engagement by the multimodal iTBS + digital mindfulness training relative to an active control training combined with iTBS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder.
- •At least one failed antidepressant medication trial at level 3 in the Antidepressant Treatment History Form: Short Form (ATHF-SF) classification.
- •Montgomery-Åsberg Depression Rating Scale (MADRS) Score >19 (moderate - severe depression).
- •No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
- •Demonstrated capacity to give informed consent.
Exclusion Criteria
- •Inability to provide informed consent.
- •Medically unstable patients.
- •Concomitant neurological disorder or a history of a seizure disorder.
- •Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS)
- •Patients who are pregnant or breastfeeding.
- •Any psychotic disorder or current active psychotic symptoms.
- •Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.
- •Contraindication to MRI scanning.
Outcomes
Primary Outcomes
Change in EEG source localized pDMN alpha activity
Time Frame: 4 weeks
EEG alpha band (8-12 Hz) activity source-localized to the posterior Default Mode Network (pDMN) brain region extracted on distracted trials of the Breath Attention Assessment of Mindfulness task serves as the primary neural target.
Secondary Outcomes
- Change in Selective Attention(4 weeks)
- Change in Flanker Inhibition(4 weeks)
- Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS)(8 weeks)
Investigators
Jyoti Mishra
Associate Professor
University of California, San Diego