Feasibility Pilot of Accelerated Stimulation With TMS for Treatment of Major Depressive Disorder (FAST-MDD)

This is a mixed-methods study that includes three steps. The first is a focus group to collect opinions and feedback about implementation of aTMS among clinicians, technicians, nurses, and other clinical staff at the St. Louis Park (SLP) clinic who are experienced with delivering TMS. The second is the delivery of a set of questionnaires delivered to TMS patients at the SLP clinic who are awaiting the start of their TMS series. The third is the delivery of aTMS utilizing the MagVenture TMS device to patients on the SLP rTMS waitlist.

The purpose of this feasibility study is to examine the acceptability and efficacy of Accelerated Transcranial Magnetic Stimulation (aTMS) delivered using an accelerated schedule. Repetitive Transcranial Magnetic Stimulation (rTMS) is traditionally delivered once a day, five days a week, for nearly 7 weeks for a total of 36 treatments. While aTMS is quick to deliver, a standard session lasting 10-20 minutes, this schedule is time intensive for patients. It often requires time off from work to accommodate daily driving time to and from the clinic as well as treatment time. This can be disruptive to a patients life and ability to attend all treatment sessions while continuing with their own life responsibilities.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Other: aTMS utilizing the MagVenture TMS device

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University Of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 70 years old
• Current patient of SLP Clinic
• Diagnosis of Unipolar Depression
• Have tried at least 1 antidepressant
• Ability to maintain stable medication regimen for duration of study

Exclusion Criteria:

• Has received TMS in the last 3 months
• Diagnosis of Bipolar Depression
• Any lifetime psychosis or mania
• Recent suicide attempt within 90 days of study visit
• Use of Benzodiazepines in past 4 weeks
• Presence of any contraindication to TMS assessed by the TMS Adult Safety Screen including individual history of uncontrolled seizures
• Current or history of alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study group; Patients with major depressive disorder

Other: aTMS utilizing the MagVenture TMS device; Participants will complete 6 MagVenture TMS sessions per day for 5 days at the SLP Clinic. Sessions will take place with at least 30 minutes between each session. The first session will determine the baseline motor threshold for delivering aTMS. We will be stimulating the dorsolateral prefrontal cortex (DLPFC) which is within the FDA approved uses. Participants will complete a PHQ9 on all 5 treatment days and 1, 2, 4, and 6 weeks post treatment via REDCap Participants will complete daily adverse event logs via REDCap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in depressive symptoms	assessed via the PHQ9, comparing baseline to end of treatment and 6 weeks post treatment.	baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability data of aTMS		0, 1, 2, 4, and 6 weeks post treatment
Dropout rate	will be calculated via completion rates	6 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2025
• Primary Completion (Actual): February 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: April 29, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 8, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: FAST-MDD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No