rTMS for MDD: 5.5cm Rule vs. F3 Targeting

Nicholas Trapp

Status: Completed

Conditions: Major Depressive Disorder; Depression

Treatments: Device: Repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03378570

201709834

Details and patient eligibility

About

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 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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 2 patient groups

5.5cm Rule Group

Active Comparator group

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.

Treatment:

Device: Repetitive transcranial magnetic stimulation

F3 Group

Active Comparator group

Description:

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

Treatment:

Device: Repetitive transcranial magnetic stimulation