Mindfulness Engaged Neurostimulation for Depression
Purpose
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.
Conditions
- Depression
- Treatment Resistant Depression
- Major Depressive Disorder
- Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Medi1-TBS |
This arm will receive a multimodal treatment with a digital mindfulness training focused on attention to breathing for up to 10 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region. |
|
|
Experimental Medi2-TBS |
This arm will receive a multimodal treatment with a digital mindfulness training focused on attention to breathing for up to 20 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region. |
|
|
Active Comparator Medi3-TBS |
This arm will receive a multimodal treatment with a digital mindfulness training focused on intermittent deep breathing for up to 10 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of California, San Diego
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.
