NCT06748209

Establishing Mobile Transcranial Magnetic Stimulation

Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this pilot study, investigators propose to design and create a portable TMS unit, in a van, and then test out delivering TMS in three different locations in South Carolina, all affiliated with MUSC and within 2-hours driving from Charleston, SC. This study would test out this new delivery mode, and provide valuable feasibility, safety, and efficacy lessons for later refinement and potential widespread adoption of mobile TMS as a treatment option, both in our state and across the US.

Detailed description

In this pilot study, investigators propose to design and create a portable TMS unit, in a van, and then test out delivering TMS in three different locations in South Carolina, all within 90 minutes driving from Charleston, SC. This study would test out this new delivery mode, and provide valuable lessons for later refinement and potential widespread adoption of mobile TMS as a treatment option. This would open up access to TMS for millions of patients with treatment resistant depression who cannot be treated in the current model. After this pilot feasibility and efficacy study, future research would use mobile TMS units for siting at residential care facilities, or remote hospitals and clinics. Investigators aim to determine whether it is possible to assemble and build a functioning mobile TMS unit. After assembling the van, investigators will then recruit up to 30 treatment-resistant depression patients who live near one of three satellite MUSC clinics. These clinics are all within a 2 hour drive from the MUSC Charleston campus. Investigators will treat these patients, open label, with FDA approved accelerated TMS (6 sessions each day, over 2 hours, for 5 days, spread over one or two weeks). Investigators will measure TMS effectiveness using standard depression rating scales. Importantly, investigators will also collect the costs of performing the TMS which will inform whether MUSC or other health delivery systems might adopt this TMS method.

Conditions

• Treatment Resistant Major Depression

Interventions

Type	Name	Description
DEVICE	Left prefrontal Transcranial Magnetic Stimulation (TMS)	FDA cleared TMS
DEVICE	FDA cleared TMS for treating depression	This is FDA approved TMS

Timeline

• Start date: 2025-05-10
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2024-12-27
• Last updated: 2025-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study