Mindfulness Engaged Neurostimulation for Depression

Depression Clinical Trial

— MEND  

Official title:

Mindfulness Engaged Neurostimulation for Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06399406
• Other study ID #: 809712
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: Jyoti Mishra, PhD
• Phone: 8582322855
• Email: braine[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 of >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.

Related Conditions & MeSH terms

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

Intervention

Combination Product:
• Medi-TBS
The multimodal intervention involves combining FDA-approved repetitive transcranial magnetic stimulation (rTMS) with digital mindfulness exercises.

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Working Memory	Span-weighted efficiency will be measured on a standard Delayed Match to Sample Task	4 weeks
Other	Change in Mindful Attention Awareness Scale (MAAS)	The MAAS will be used to evaluate change in subjective state mindfulness. Scale range: 6-84, higher score is greater mindfulness	4 weeks
Other	Change in Rumination Reflection Questionnaire (RRQ)	The RRQ will be used to evaluate change in subjective rumination. Scale range: 22-88, higher score is greater rumination	4 weeks
Other	Change in Patient Health Questionnaire 9 item scale (PHQ9)	The PHQ9 scale will be used as an additional measure to evaluate change in depressive symptom response. Score range: 0-27, higehr score is greater depression	8 weeks
Other	Change in Generalized Anxiety Disorder 7 item scale (GAD7)	The GAD7 scale will be used as a measure to evaluate change in anxiety symptom response.; Score range: 0-21, higher score is greater anxiety	8 weeks
Primary	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	Change in Selective Attention	Processing speed of response to target stimuli on a standard continuous performance task that measures the ability to selectively attend and promptly respond to a goal-relevant target stimulus serves as the secondary cognitive target.	4 weeks
Secondary	Change in Flanker Inhibition	Efficiency of inhibiting visuo-spatially flanking distractors to target stimuli in the Flanker task serves as the secondary cognitive target.	4 weeks
Secondary	Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS)	The MADRS will be used to evaluate % depressive symptom response defined as 50% change in the MADRS score from baseline as well as remission defined as MADRS score <7 at post-intervention. Scale range: 0-54, higher score is worse depression.	8 weeks