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Treatment of Depression With Connectivity Guided Robotically Delivered rTMS

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ClinicalTrials.gov Identifier: NCT02802293
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
IKARE Mood, Trauma, Recovery Clinic
Information provided by (Responsible Party):
Felipe Salinas, The University of Texas Health Science Center at San Antonio

Brief Summary:
The purpose of this study is to determine the clinical effects (if any) of connectivity-guided repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depressive disorder (MDD) to provide clues about the ideal neural networks to target for more robust clinical outcomes, and to identify potential biomarkers of treatment response including changes in brain network connectivity.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: repetitive transcranial magnetic stimulation Device: robotic arm Not Applicable

Detailed Description:
The investigators propose a randomized, double-blind, 4-week trial of TMS to the left dorsolateral prefrontal cortex (DLPFC) for subjects with MDD all of whom at the patient's treatment clinic are concurrently receiving pharmaceutical and psychotherapeutic interventions. Arm 1 delivers active rTMS to the left DLPFC using the standard aiming strategy. Arm 2 delivers active rTMS to the left anterior DLPFC using connectivity-based, image-guided aiming. Arm 3 delivers active rTMS to the left posterior DLPFC using connectivity-based, image-guided aiming. In all three arms, rTMS is administered in an image-guided, robotically-positioned TMS (irTMS) manner to ensure therapist blinding and equivalent subject experiences across arms. In all three arms, the following stimulation protocol will be used: 10 Hz irTMS delivered 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. Neuroimaging will be used both for treatment planning and to characterize any TMS-induced network plasticity using resting-state functional magnetic resonance imaging (rs-fMRI) at week 4 of each treatment arm. Clinical assessments will be administered weekly throughout treatment (weeks 1-4) at the patient's treatment clinic. Additional psychological tests will be performed at UT Health—San Antonio's Research Imaging Institute (RII) at the baseline and post-treatment visits in order to track patient progress.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Depression With Connectivity Guided Robotically Delivered Repetitive Transcranial Magnetic Stimulation
Actual Study Start Date : August 17, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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.
Device: repetitive transcranial magnetic stimulation
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 Name: rTMS

Device: robotic arm
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.
Device: repetitive transcranial magnetic stimulation
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 Name: rTMS

Device: robotic arm
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.
Device: repetitive transcranial magnetic stimulation
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 Name: rTMS

Device: robotic arm
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.




Primary Outcome Measures :
  1. Change in depression severity (MADRS) [ Time Frame: Baseline to four weeks (the conclusion of rTMS treatment) ]
    Measured by the Montgomery-Ashberg Depression Rating Scale


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) ]
    Types and rates of adverse events will be summarized and compared across the study groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females with MDD receiving treatment at the iKare Mood Trauma Recovery Clinic between the ages of 18-65 years;
  2. 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)
  3. 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.
  4. 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.
  5. Able to provide written informed consent.
  6. Able to read and write English.

Exclusion Criteria:

  1. Subjects with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as confirmed by MINI.
  2. 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.
  3. Substance use disorder during the 3 months prior to screening; except for Mild or Moderate Alcohol Use Disorder according to DSM-V criteria.
  4. 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.
  5. Females will be excluded if they are pregnant (i.e. positive pregnancy test identified after their intake at the treatment clinic).
  6. 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).
  7. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802293


Contacts
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Contact: Felipe S Salinas, Ph.D. 210-567-8214 salinasf@uthscsa.edu
Contact: Marlon Quinones, M.D. 210-802-2340 quinonesm@first-md.org

Locations
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United States, Texas
Ikare, Mood, Trauma, Recovery Clinic Recruiting
San Antonio, Texas, United States, 78229
Contact: Marlon Quinones, MD    210-802-2340      
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
IKARE Mood, Trauma, Recovery Clinic
Investigators
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Principal Investigator: Felipe S Salinas, Ph.D. The University of Texas Health Science Center at San Antonio

Publications:
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Responsible Party: Felipe Salinas, Research Scientist--Senior, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02802293     History of Changes
Other Study ID Numbers: CE-MDD-LRTC
HSC20160129H ( Other Identifier: UTHSCSA )
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Felipe Salinas, The University of Texas Health Science Center at San Antonio:
Repetitive Transcranial Magnetic Stimulation
Major Depressive Disorder
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders