Mindfulness Engaged Neurostimulation for Depression

NCT06399406 | Active Not Recruiting Phase 2 FDA Device

• 1 other identifier: MEND I
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Treatment Resistant Depression; Major Depressive Disorder; Depressive Disorder

Keywords

rTMS; mindfulness; depression

Outcome Measures

Primary Outcomes (1)

• Change in EEG source localized pDMN alpha activity

  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.

  4 weeks

Secondary Outcomes (3)

• Change in Selective Attention

  4 weeks

• Change in Flanker Inhibition

  4 weeks

• Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS)

  8 weeks

Other Outcomes (5)

• Change in Working Memory

  4 weeks

• Change in Mindful Attention Awareness Scale (MAAS)

  4 weeks

• Change in Rumination Reflection Questionnaire (RRQ)

  4 weeks

Study Arms (3)

Medi1-TBS

EXPERIMENTAL

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.

Combination Product: Medi-TBS

Medi2-TBS

EXPERIMENTAL

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.

Combination Product: Medi-TBS

Medi3-TBS

ACTIVE COMPARATOR

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.

Combination Product: Medi-TBS

Interventions

Medi-TBS COMBINATION_PRODUCT

The multimodal intervention involves combining FDA-approved repetitive transcranial magnetic stimulation (rTMS) with digital mindfulness exercises.

Medi1-TBS; Medi2-TBS; Medi3-TBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major; Depressive Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Jyoti Mishra, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: May 15, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: We will submit raw/descriptive data semi-annually (every January and July) and submit all other data at the time of publication of the initial report from the project.
• Access Criteria: Access to study data will be available via the NDCT.

Locations

US (1)