Clinical trial NCT03378570: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Depression
Keywords: Transcranial Magnetic Stimulation
rTMS
F3
5.5cm rule
Targeting
TMS
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage Change in Patient Health Questionnaire 9-Item Assessment Score
timeFrame: 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.
measure: Percentage Change in Montgomery-Asberg Depression Rating Scale Score
timeFrame: 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.
measure: Percentage Change in General Anxiety Disorder 7-Item Assessment Score
timeFrame: 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.
measure: Response and Remission Rates on Patient Health Questionnaire 9-Item Assessment
timeFrame: 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.
measure: Response and Remission Rates on Montgomery-Asberg Depression Rating Scale
timeFrame: 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.
measure: Response Rates on General Anxiety Disorder 7-Item Assessment
timeFrame: 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.
Secondary outcomes:
measure: Montreal Cognitive Assessment Score Changes
timeFrame: 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.
measure: Emotion Measures
timeFrame: 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.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Nicholas T Trapp, M.D.
role: PRINCIPAL_INVESTIGATOR
References: