rTMS for MDD: 5.5cm Rule vs. F3 Targeting

NCT03378570 | Completed Results FDA Device

• 1 other identifier: 201709834
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Depression

Keywords

Transcranial Magnetic Stimulation; rTMS; F3; 5.5cm rule; Targeting; TMS

Outcome Measures

Primary Outcomes (6)

• Percentage Change in Patient Health Questionnaire 9-Item Assessment Score

  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.

  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.

• Percentage Change in Montgomery-Asberg Depression Rating Scale Score

  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.

  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.

• Percentage Change in General Anxiety Disorder 7-Item Assessment Score

  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.

  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.

• Response and Remission Rates on Patient Health Questionnaire 9-Item Assessment

  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.

  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.

• Response and Remission Rates on Montgomery-Asberg Depression Rating Scale

  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.

• Response Rates on General Anxiety Disorder 7-Item Assessment

  Comparison of the response rate (\>50% improvement) for the General Anxiety Disorder 7-Item Assessment 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.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

5.5cm Rule Group

ACTIVE COMPARATOR

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.

Device: Repetitive transcranial magnetic stimulation

F3 Group

ACTIVE COMPARATOR

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

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation 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.

5.5cm Rule Group; F3 Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicholas Trapp: lead

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 37714408 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

* The study study sample included many people with significant psychiatric comorbidities, was predominately white and non-Hispanic, and did not standardize or control medication changes. * Subjects were not randomized into iTBS or 10 Hz. * There was lack of assessment of blinding. * This study excluded participants with a head circumference \>60 cm. * Due to the naturalistic sample, a cut-off of having received at least 20 treatments was used for inclusion in the primary analysis.

Results Point of Contact

• Title: Dr. Nicholas Trapp
• Organization: University of Iowa Hospitals & Clinics

nicholas-trapp@uiowa.edu

(319) 467-8188

Study Officials

• Nicholas T Trapp, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician-Associate and Neuromodulation Fellow

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: May 1, 2018
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)