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

University of Minnesota (UMN)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Major Depressive Disorder

Treatments: Other: aTMS utilizing the MagVenture TMS device

Study type: Interventional

Funder types: Other

Identifiers

NCT06961851

FAST-MDD

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Study group

Experimental group

Description:

Patients with major depressive disorder

Treatment:

Other: aTMS utilizing the MagVenture TMS device