rTMS for MDD: 5.5cm Rule vs. F3 Targeting

Overview

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.

Full Title of Study: “The Effects of Repetitive Transcranial Magnetic Stimulation Prefrontal Target Location on Outcomes for Major Depressive Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 13, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: F3 Group
    • rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nicholas Trapp
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Nicholas Trapp, Physician-Associate and Neuromodulation Fellow – University of Iowa
  • Overall Official(s)
    • Nicholas T Trapp, M.D., Principal Investigator, University of Iowa

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