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

NCT ID: NCT06961851

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-09
• Study Completion Date: 2026-02-01

Brief Summary

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Patients with major depressive disorder

Group Type: EXPERIMENTAL

aTMS utilizing the MagVenture TMS device

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

FAST-MDD

Identifier Type: -

Identifier Source: org_study_id