Mindfulness Engaged Neurostimulation for Depression

Description

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

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Study Overview

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Study Details

Study overview

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.

Mindfulness Engaged Neurostimulation for Depression

Mindfulness Engaged Neurostimulation for Depression

Condition
Depression
Intervention / Treatment

-

Contacts and Locations

La Jolla

University of California San Diego, La Jolla, California, United States, 92093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Diego,

Jyoti Mishra, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

2026-04-30