rTMS for MDD: 5.5cm Rule vs. F3 Targeting

Not Applicable

Completed

Conditions: Depression
Major Depressive Disorder

Interventions: Device: Repetitive transcranial magnetic stimulation

Registration Number: NCT03378570

Lead Sponsor: Nicholas Trapp

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 123

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5.5cm Rule Group	Repetitive transcranial magnetic stimulation	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.
F3 Group	Repetitive transcranial magnetic stimulation	rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.

Primary Outcome Measures

Name	Time	Method
Percentage Change in Patient Health Questionnaire 9-Item Assessment Score	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 Patient Health Questionnaire 9-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assessment measures depression severity at baseline. Total scores of 5, 10, 15, and 20 represent markers for mild, moderate, moderately severe, and severe depression, respectively. All 9 items are summed to compute a total score, ranging from 0-27. Higher scores indicate more severe self-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms.
Percentage Change in Montgomery-Asberg Depression Rating Scale Score	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 Montgomery-Asberg Depression Rating Scale score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This scale assesses depression severity at baseline. Scores of 8, 17, and 34 are cut-off points for mild, moderate, severe depression, respectively. This 10 item scale is summed to compute a total score, ranging from 0-60. Higher scores indicate more severe clinician-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms.
Percentage Change in General Anxiety Disorder 7-Item Assessment Score	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 General Anxiety Disorder 7-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assesses anxiety severity as baseline. Scores of 5, 10, and 15 are cut-off points for mild, moderate, and severe anxiety, respectively. All 7 items are summed to compute a total score, ranging from 0-21. Higher scores indicate more severe self-rated anxiety symptoms. Negative change from baseline implies a decrease in anxiety symptoms.
Response and Remission Rates on Patient Health Questionnaire 9-Item 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.	Comparison of the response rate (\>50% improvement) and remission rate (score \<5) for the Patient Health Questionnaire 9-Item Assessment between the 2 groups post-treatment.
Response and Remission Rates on Montgomery-Asberg Depression Rating Scale	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.
Response Rates on General Anxiety Disorder 7-Item 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.	Comparison of the response rate (\>50% improvement) for the General Anxiety Disorder 7-Item Assessment between the 2 groups post-treatment.

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment Score Changes	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.	Change in Montreal Cognitive Assessment scores from baseline to final timepoint. Reported here as the mean difference in total Montreal Cognitive Assessment score from baseline to endpoint. Montreal Cognitive Assessment is used a screen for cognitive impairment, calculated by adding the points from each task, which range from 0-30. Higher scores indicate little to no cognitive impairment 26 or above: Normal cognition 18-25: Mild cognitive impairment 10-17: Moderate cognitive impairment Fewer than 10: Severe cognitive impairment
Emotion Measures	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.	T Score Changes in National Institutes of Health Toolbox Emotional Battery A T score of 50 corresponds to the population mean. Scores may range from 20-80 with a standard deviation of 10. Higher T scores indicate a higher endorsement of each domain. Here, we present changes in mean score from pre-treatment to post-treatment. In that way, a positive value represents a decrease in average T score, and vice versa.