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rTMS for MDD: 5.5cm Rule vs. F3 Targeting

Primary Purpose

Major Depressive Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sponsored by
Nicholas Trapp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Transcranial Magnetic Stimulation, rTMS, TMS, F3, 5.5cm rule, Targeting

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Iowa Hospitals & Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

5.5cm Rule Group

F3 Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Percentage change in MADRS score
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
Comparison of the response rate (>50% improvement) and remission rate (score <10) for the MADRS between the 2 groups post-treatment.
Personality measures
Changes in the Temperament and Character Inventory subscales
Clinical Global Impression Scale
CGI comparing pre- to post-treatment.
PHQ9 changes
Comparison of percentage change in PHQ9 pre- to post-treatment.
Montreal Cognitive Assessment (MOCA) score changes
Changes in MOCA scores
Cognitive measures
Changes in NIH Toolbox Cognitive Battery
Emotion measures
Changes in NIH Toolbox Emotional Battery
Functional MRI changes
Changes in functional connectivity resting-state MRI pre- to post-treatment
Structural MRI changes
Changes in structural and volumetrics on MRI pre- to post-treatment
Neurobehavioral battery changes
Changes in scores on a novel neurobehavioral assessment

Secondary Outcome Measures

Full Information

First Posted
December 14, 2017
Last Updated
February 15, 2023
Sponsor
Nicholas Trapp
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1. Study Identification

Unique Protocol Identification Number
NCT03378570
Brief Title
rTMS for MDD: 5.5cm Rule vs. F3 Targeting
Official Title
The Effects of Repetitive Transcranial Magnetic Stimulation Prefrontal Target Location on Outcomes for Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicholas Trapp

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Depression
Keywords
Transcranial Magnetic Stimulation, rTMS, TMS, F3, 5.5cm rule, Targeting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5.5cm Rule Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
F3 Group
Arm Type
Active Comparator
Arm Description
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
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 Measure Information:
Title
Percentage change in MADRS score
Description
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.
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.
Title
Response and remission rates on MADRS
Description
Comparison of the response rate (>50% improvement) and remission rate (score <10) for the MADRS between the 2 groups post-treatment.
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.
Title
Personality measures
Description
Changes in the Temperament and Character Inventory subscales
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.
Title
Clinical Global Impression Scale
Description
CGI comparing pre- to post-treatment.
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.
Title
PHQ9 changes
Description
Comparison of percentage change in PHQ9 pre- to post-treatment.
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.
Title
Montreal Cognitive Assessment (MOCA) score changes
Description
Changes in MOCA scores
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.
Title
Cognitive measures
Description
Changes in NIH Toolbox Cognitive Battery
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.
Title
Emotion measures
Description
Changes in NIH Toolbox Emotional Battery
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.
Title
Functional MRI changes
Description
Changes in functional connectivity resting-state MRI pre- to post-treatment
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.
Title
Structural MRI changes
Description
Changes in structural and volumetrics on MRI pre- to post-treatment
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.
Title
Neurobehavioral battery changes
Description
Changes in scores on a novel neurobehavioral assessment
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas T Trapp, M.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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rTMS for MDD: 5.5cm Rule vs. F3 Targeting

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