- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02802293
Treatment of Depression With Connectivity Guided Robotically Delivered rTMS
Treatment of Depression With Connectivity Guided Robotically Delivered Repetitive Transcranial Magnetic Stimulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Ikare, Mood, Trauma, Recovery Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females with MDD receiving treatment at the iKare Mood Trauma Recovery Clinic between the ages of 18-65 years;
- Meeting the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for MDD as determined using the Mini-International Psychiatric Interview (MINI)
- Meeting the Patient Health Questionnaire-9 (PHQ-9 > 14) and/or the Structured Interview Guide for the Montgomery-Ashberg Depression Rating Scale (SIGMA>18) criteria for treatment resistance in MDD despite completing at least one adequate trial of an Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) at an FDA-recommended dose for at least 6-8 weeks.
- Subjects on SSRIs or other antidepressants, hypnotic medications including modulators of Gamma-Aminobutryic Acid (GABA)-A receptor function, trazodone, atypical neuroleptic or other psychotropic medications such as prazosin may enter the study if they are deemed to be on a stable dose of their medication.
- Able to provide written informed consent.
- Able to read and write English.
Exclusion Criteria:
- Subjects with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as confirmed by MINI.
- Serious, active suicidal risk as assessed by evaluating psychiatrist. Serious active suicidal risk is determine as imminent risk of suicide reflected in a subject having a plan and intent to end his or her life. History of suicidality in itself is not exclusion for participation in this protocol so long as the evaluating psychiatrist determines that there is an absence of serious active suicidal risk and the means to keep subjects safe.
- Substance use disorder during the 3 months prior to screening; except for Mild or Moderate Alcohol Use Disorder according to DSM-V criteria.
- Any history or signs of serious medical or neurological illness including seizure disorders. Except for seizures, a subject with a clinical abnormality may be included only if the study clinician considers the illness will not introduce additional risk and will not interfere with the study procedures.
- Females will be excluded if they are pregnant (i.e. positive pregnancy test identified after their intake at the treatment clinic).
- History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more as determined by the Brief Traumatic Brain Injury Screen (TBI Screening Tool).
- Any history or signs of metal objects (e.g. surgical clips, cardiac pacemakers, metal implants, etc.) in the body at the time of screening. MRI can have risks for persons with foreign bodies implanted in their body.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard rTMS Aiming
Active repetitive transcranial magnetic stimulation (rTMS) will be delivered to the left DLPFC using the standard aiming strategy with the rTMS coil positioned using a robotic arm.
In this arm, rTMS will be delivered at 10 Hz in 4 sec trains with 26 sec inter-train intervals, 37.5 minutes/session (i.e.
3,000 pulses/session), 5 sessions/week, for 4 weeks.
|
The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use.
The non-invasive brain stimulation system will be used to deliver repetitive electromagnetic pulses in this research study's treatment of major depressive disorder.
Other Names:
This robotic system is based on a commercially available neurosurgical robot.
The robot is mounted on a mobile (i.e.
retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer.
The robotic system will be used for TMS coil positioning/targeting.
|
Active Comparator: Anterior DLPFC targeting
Active rTMS will be delivered to the left anterior DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
In this arm, rTMS will be delivered at 10 Hz in 4 sec trains with 26 sec inter-train intervals, 37.5 minutes/session (i.e.
3,000 pulses/session), 5 sessions/week, for 4 weeks.
|
The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use.
The non-invasive brain stimulation system will be used to deliver repetitive electromagnetic pulses in this research study's treatment of major depressive disorder.
Other Names:
This robotic system is based on a commercially available neurosurgical robot.
The robot is mounted on a mobile (i.e.
retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer.
The robotic system will be used for TMS coil positioning/targeting.
|
Active Comparator: Posterior DLPFC targeting
Active rTMS will be delivered to the left posterior DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
In this arm, rTMS will be delivered at 10 Hz in 4 sec trains with 26 sec inter-train intervals, 37.5 minutes/session (i.e.
3,000 pulses/session), 5 sessions/week, for 4 weeks.
|
The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use.
The non-invasive brain stimulation system will be used to deliver repetitive electromagnetic pulses in this research study's treatment of major depressive disorder.
Other Names:
This robotic system is based on a commercially available neurosurgical robot.
The robot is mounted on a mobile (i.e.
retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer.
The robotic system will be used for TMS coil positioning/targeting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Severity (MADRS)
Time Frame: Baseline to four weeks (the conclusion of rTMS treatment)
|
Measured by the Montgomery-Ashberg Depression Rating Scale. This is a 10-item diagnostic questionnaire with an overall score range from 0 to 60. A higher score indicates more severe depression: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. |
Baseline to four weeks (the conclusion of rTMS treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Severity (MADRS)
Time Frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
|
Measured by the Montgomery-Ashberg Depression Rating Scale. This is a 10-item diagnostic questionnaire with an overall score range from 0 to 60. A higher score indicates more severe depression: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. |
Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
|
Clinically Significant Response (MADRS)
Time Frame: Baseline to four weeks (the conclusion of rTMS treatment)
|
Defined as greater than or equal to a 50% decrease in the Montgomery-Ashberg Depression Rating Scale. This is a 10-item diagnostic questionnaire with an overall score range from 0 to 60. A higher score indicates more severe depression: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. |
Baseline to four weeks (the conclusion of rTMS treatment)
|
Clinically Significant Response (MADRS)
Time Frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
|
Defined as greater than or equal to a 50% decrease in the Montgomery-Ashberg Depression Rating Scale. This is a 10-item diagnostic questionnaire with an overall score range from 0 to 60. A higher score indicates more severe depression: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. |
Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
|
Remission From Depression (MADRS)
Time Frame: Baseline to four weeks (the conclusion of rTMS treatment)
|
Defined as Montgomery-Ashberg Depression Rating Scale score less than or equal to 10. This is a 10-item diagnostic questionnaire with an overall score range from 0 to 60. A higher score indicates more severe depression: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. |
Baseline to four weeks (the conclusion of rTMS treatment)
|
Remission From Depression (MADRS)
Time Frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
|
Defined as Montgomery-Ashberg Depression Rating Scale score less than or equal to 10. This is a 10-item diagnostic questionnaire with an overall score range from 0 to 60. A higher score indicates more severe depression: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. |
Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
|
Functional Connectivity Changes of the Targeted Brain Network(s) Following rTMS Treatment
Time Frame: Baseline to four weeks (the conclusion of rTMS treatment)
|
resting-state fMRI scan will also be used to assess, network-specific functional connectivity differences between each subject's pre-treatment and post-treatment scans. The purpose of the Z score is to "standardize" distributions so that each has a mean of 0, and standard deviation as 1, so we can then make comparisons. Standard Score, the "Z-Score": A way to make a comparison between values on two different normal curves by converting the values to the number of standard deviations above or below the mean. |
Baseline to four weeks (the conclusion of rTMS treatment)
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20160129H (Other Identifier: UTHSCSA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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