rTMS for MDD: 5.5cm Rule vs. F3 Targeting

Depression Clinical Trial

Official title:

The Effects of Repetitive Transcranial Magnetic Stimulation Prefrontal Target Location on Outcomes for Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378570
• Other study ID #: 201709834
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 13, 2022

Study information

• Verified date: February 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Nicholas Trapp

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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.
Primary	Personality measures	Changes in the Temperament and Character Inventory subscales	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.
Primary	Clinical Global Impression Scale	CGI comparing pre- to post-treatment.	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.
Primary	PHQ9 changes	Comparison of percentage change in PHQ9 pre- to post-treatment.	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.
Primary	Montreal Cognitive Assessment (MOCA) score changes	Changes in MOCA scores	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.
Primary	Cognitive measures	Changes in NIH Toolbox Cognitive Battery	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.
Primary	Emotion measures	Changes in NIH Toolbox Emotional Battery	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.
Primary	Functional MRI changes	Changes in functional connectivity resting-state MRI pre- to post-treatment	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.
Primary	Structural MRI changes	Changes in structural and volumetrics on MRI pre- to post-treatment	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.
Primary	Neurobehavioral battery changes	Changes in scores on a novel neurobehavioral assessment	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.