DepressionMediTMSNCT04586699
Meditation Accelerated Brain Stimulation for Depression
A study testing Medi1TMS and Medi2TMS in people with Depression, run by University of California, San Diego at 2 sites in United States.
Trial summary
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Medi1TMS and Medi2TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate to severe depression (PHQ-9 scale score >9 with confirmation using the Structured Clinical Interview for DSM-5 Disorders)
- treatment refractory to antidepressants (i.e. failed 1-3 antidepressants in current episode) or intolerant to antidepressants (i.e. tried 2 antidepressant of inadequate dose/duration in current episode)
Who cannot join
- active substance abuse/dependence
- psychotic disorders
- any factor that increases risk of TMS (metal implants/history of stroke/seizure disorder).
- displaying acutely suicidal behaviors on the Columbia Suicide Severity Rating Scale.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Neuromodulation Clinic Veterans Affairs San Diego
San Diego, California, 92037
UC San Diego Health Psychiatry
San Diego, California, 92127
About this study
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from ~15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention.
Read the detailed description
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from ~15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention. Meditative internal focus has been shown to benefit depression. Our own research shows that the neural correlates of attention-to-breath are associated with greater mindfulness. Hence, in this study we will pair breath training with rTMS neuro-stimulation.
- Conditions
- Depression
- Being tested
- Medi1TMS, Medi2TMS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medi1TMSDevice
rTMS theta-burst protocol paired with a consistent attention-to-breath task
Medi2TMSDevice
rTMS theta-burst protocol paired with an intermittent deep breathing task
| Study group | Role | What they receive |
|---|---|---|
| Medi1TMS | Experimental | rTMS theta-burst protocol paired with a consistent attention-to-breath task Receives: Device: Medi1TMS |
| Medi2TMS | Active comparator | rTMS theta-burst protocol paired with an intermittent deep breathing task Receives: Device: Medi2TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Clinical Depression (Remission)
Remission is defined by achieving <5 score on the Patient Health Questionnaire 9-item depression scale at post-intervention. This scale ranges in score from 0-27; higher score is worse depression.
Measured: up to 6 weeks
Change From Baseline Brain Activity in Attention-to-breath Task
Change from baseline brain activity is specifically change in source-localized electroencephalography (EEG) alpha band power. The unit of measure is log (uA/mm^2), which represents the transformation of EEG signals recorded at scalp electrodes in microvolts into a log-scaled estimate of cortical current source density after source reconstruction. A value of 0 means the current density is exactly 1 since log(1) = 0. Negative values indicate weak cortical source currents fractional to a microampere (e.g. -1 equals 0.1 uA/mm^2). Positive values represent stronger activity.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Jul 2021
- Primary completion15 Apr 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jyoti Mishra, University of California, San Diego
- Investigators
- Jyoti Mishra, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586699
- Sponsor's protocol ID
- MediTMS
- Acronym
- MediTMS
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2020
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified raw and processed data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation Accelerated Brain Stimulation for Depression
- ClinicalTrials.gov ID
- NCT04586699
- Acronym / sponsor ID
- MediTMS / MediTMS
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 11 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from ~15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention.
Detailed description
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from ~15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention. Meditative internal focus has been shown to benefit depression. Our own research shows that the neural correlates of attention-to-breath are associated with greater mindfulness. Hence, in this study we will pair breath training with rTMS neuro-stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Medi1TMS | Experimental | Device: Medi1TMSrTMS theta-burst protocol paired with a consistent attention-to-breath task |
| Medi2TMS | Active comparator | Device: Medi2TMSrTMS theta-burst protocol paired with an intermittent deep breathing task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- moderate to severe depression (PHQ-9 scale score >9 with confirmation using the Structured Clinical Interview for DSM-5 Disorders)
- treatment refractory to antidepressants (i.e. failed 1-3 antidepressants in current episode) or intolerant to antidepressants (i.e. tried 2 antidepressant of inadequate dose/duration in current episode)
Key exclusion criteria (4 listed)
- active substance abuse/dependence
- psychotic disorders
- any factor that increases risk of TMS (metal implants/history of stroke/seizure disorder).
- displaying acutely suicidal behaviors on the Columbia Suicide Severity Rating Scale.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medi1TMSrTMS theta-burst protocol paired with a consistent attention-to-breath task | Device | Medi1TMS |
| Medi2TMSrTMS theta-burst protocol paired with an intermittent deep breathing task | Device | Medi2TMS |
Primary outcome
Change From Baseline Clinical Depression (Remission)
Time frame: up to 6 weeks
Remission is defined by achieving <5 score on the Patient Health Questionnaire 9-item depression scale at post-intervention. This scale ranges in score from 0-27; higher score is worse depression.
Change From Baseline Brain Activity in Attention-to-breath Task
Time frame: up to 6 weeks
Change from baseline brain activity is specifically change in source-localized electroencephalography (EEG) alpha band power. The unit of measure is log (uA/mm^2), which represents the transformation of EEG signals recorded at scalp electrodes in microvolts into a log-scaled estimate of cortical current source density after source reconstruction. A value of 0 means the current density is exactly 1 since log(1) = 0. Negative values indicate weak cortical source currents fractional to a microampere (e.g. -1 equals 0.1 uA/mm^2). Positive values represent stronger activity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified raw and processed data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jyoti Mishra, PhD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medi1TMS and Medi2TMS in people with Depression, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Clinical Depression (Remission) (time frame: up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.