Meditation Accelerated Brain Stimulation for Depression (MediTMS)
Primary Purpose
Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medi1TMS
Medi2TMS
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- Neuromodulation Clinic Veterans Affairs San DiegoRecruiting
- UC San Diego Health PsychiatryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medi1TMS
Medi2TMS
Arm Description
rTMS theta-burst protocol paired with a consistent attention-to-breath task
rTMS theta-burst protocol paired with an intermittent deep breathing task
Outcomes
Primary Outcome Measures
Change from baseline Clinical Depression (Remission)
PHQ9 depression scale
Change from baseline brain activity in attention-to-breath task
Electroencephalography (EEG) power in attention-to-breath task
Secondary Outcome Measures
Full Information
NCT ID
NCT04586699
First Posted
September 30, 2020
Last Updated
August 2, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04586699
Brief Title
Meditation Accelerated Brain Stimulation for Depression
Acronym
MediTMS
Official Title
Meditation Accelerated Brain Stimulation for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medi1TMS
Arm Type
Experimental
Arm Description
rTMS theta-burst protocol paired with a consistent attention-to-breath task
Arm Title
Medi2TMS
Arm Type
Active Comparator
Arm Description
rTMS theta-burst protocol paired with an intermittent deep breathing task
Intervention Type
Device
Intervention Name(s)
Medi1TMS
Intervention Description
rTMS theta-burst protocol paired with a consistent attention-to-breath task
Intervention Type
Device
Intervention Name(s)
Medi2TMS
Intervention Description
rTMS theta-burst protocol paired with an intermittent deep breathing task
Primary Outcome Measure Information:
Title
Change from baseline Clinical Depression (Remission)
Description
PHQ9 depression scale
Time Frame
up to 6 weeks
Title
Change from baseline brain activity in attention-to-breath task
Description
Electroencephalography (EEG) power in attention-to-breath task
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jyoti Mishra, PhD
Phone
(858) 822-0568
Email
jymishra@ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dhakshin Ramanathan, MDPhD
Phone
(858) 822-0568
Email
dramanathan@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyoti Mishra, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuromodulation Clinic Veterans Affairs San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dhakshin Ramanathan, MDPhD
Email
dramanathan@ucsd.edu
Facility Name
UC San Diego Health Psychiatry
City
San Diego
State/Province
California
ZIP/Postal Code
92127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyoti Mishra, PhD
Phone
858-822-0568
Email
jymishra@ucsd.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified raw and processed data will be shared with other researchers.
IPD Sharing Time Frame
At time of publication
IPD Sharing Access Criteria
The PI will review sharing requests and provide access to researchers.
Learn more about this trial
Meditation Accelerated Brain Stimulation for Depression
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