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rTMS for MDD: 5.5cm Rule vs. F3 Targeting

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ClinicalTrials.gov Identifier: NCT03378570
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nicholas Trapp, University of Iowa

Brief Summary:
The purpose of this study is to examine the effects of different treatment locations using repetitive transcranial magnetic stimulation (rTMS) to treat major depressive disorder.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Depression Device: Repetitive transcranial magnetic stimulation Not Applicable

Detailed Description:
Currently there is little standardization between rTMS treatment programs as to what is the best way to localize the left dorsolateral prefrontal cortex, which is the FDA-approved treatment location for clinical rTMS for major depressive disorder (MDD). Different targeting methods yield locations that can vary by up to a few centimeters. By comparing different treatment locations and obtaining neurobehavioral, neuroimaging, cognitive, and neuropsychological measures, this study would provide the opportunity to identify the optimal treatment targeting method when using rTMS for major depressive disorder in a clinical setting. This study will specifically be focusing on comparing the two most common targeting methods: a target 5.5cm anterior to the motor strip on the left prefrontal scalp and the F3 target location on the left prefrontal scalp as identified using the 10-20 EEG system nomenclature.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Repetitive Transcranial Magnetic Stimulation Prefrontal Target Location on Outcomes for Major Depressive Disorder
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 5.5cm Rule Group
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Device: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.

Active Comparator: F3 Group
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Device: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.




Primary Outcome Measures :
  1. Percentage change in MADRS score [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Overall change in total MADRS score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other.

  2. Response and remission rates on MADRS [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Comparison of the response rate (>50% improvement) and remission rate (score <10) for the MADRS between the 2 groups post-treatment.

  3. Personality measures [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Changes in the Temperament and Character Inventory subscales

  4. Clinical Global Impression Scale [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    CGI comparing pre- to post-treatment.

  5. PHQ9 changes [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Comparison of percentage change in PHQ9 pre- to post-treatment.

  6. Montreal Cognitive Assessment (MOCA) score changes [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Changes in MOCA scores

  7. Cognitive measures [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Changes in NIH Toolbox Cognitive Battery

  8. Emotion measures [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Changes in NIH Toolbox Emotional Battery

  9. Functional MRI changes [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Changes in functional connectivity resting-state MRI pre- to post-treatment

  10. Structural MRI changes [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Changes in structural and volumetrics on MRI pre- to post-treatment

  11. Neurobehavioral battery changes [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. ]
    Changes in scores on a novel neurobehavioral assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder
  • Age between 18 and 90 years
  • rTMS is clinically indicated as determined by clinical rTMS physician team at University of Iowa

Exclusion Criteria:

  • rTMS contraindication such as implanted ferromagnetic material in the head or history of epilepsy with poorly controlled seizures
  • MRI exclusion criteria (if participating in MRI portion of study) including implanted device such as:
  • Pacemaker
  • Coronary Stent
  • Defibrillator
  • Neurostimulation
  • Or any of the following conditions:
  • Claustrophobia
  • Uncontrolled high blood pressure
  • Poorly controlled atrial fibrillation
  • Significant heart disease
  • Hemodynamic instability
  • Severe kidney disease
  • Pregnant, trying to become pregnant, or breast feeding

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): NCT03378570


Contacts
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Contact: Amanda Heinzerling 319-384-7746 amanda-heinzerling@uiowa.edu
Contact: Nicholas T Trapp, M.D. 319-467-8188 nicholas-trapp@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Amanda Heinzerling    319-384-7746    amanda-heinzerling@uiowa.edu   
Contact: Nicholas T Trapp, M.D.    319-467-8188    brain-stim@healthcare.uiowa.edu   
Sponsors and Collaborators
Nicholas Trapp

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Responsible Party: Nicholas Trapp, Physician-Associate and Neuromodulation Fellow, University of Iowa
ClinicalTrials.gov Identifier: NCT03378570     History of Changes
Other Study ID Numbers: 201709834
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Nicholas Trapp, University of Iowa:
Transcranial Magnetic Stimulation
rTMS
TMS
F3
5.5cm rule
Targeting

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms