rTMS for MDD: 5.5cm Rule vs. F3 Targeting

NCT ID: NCT03378570

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2022-09-13

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.

Conditions

Major Depressive Disorder; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

5.5cm Rule Group

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.

Group Type: ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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.

F3 Group

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

Group Type: ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nicholas Trapp

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Trapp

Physician-Associate and Neuromodulation Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicholas T Trapp, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Countries

United States

References

Trapp NT, Pace BD, Neisewander B, Ten Eyck P, Boes AD. A randomized trial comparing beam F3 and 5.5 cm targeting in rTMS treatment of depression demonstrates similar effectiveness. Brain Stimul. 2023 Sep-Oct;16(5):1392-1400. doi: 10.1016/j.brs.2023.09.006. Epub 2023 Sep 14.

Reference Type: DERIVED

PMID: 37714408 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

201709834

Identifier Type: -

Identifier Source: org_study_id