Establishing Mobile Transcranial Magnetic Stimulation

Phase 4

Recruiting

• Conditions: Treatment Resistant Major Depression

• Registration Number: NCT06748209
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Status Verified: 2025-05
• Study Start: 2025-05-10
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18
• Primary Completion: 2027-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult (22-80 years old)
• Have treatment-resistant depression as defined by the e-Mini, and the antidepressant treatment history form (ATHF short).
• Be able to read and communicate in English.
• Able to provide their own consent.
• Access to a computer with videoconferencing ability for initial consent and telescreen.

Exclusion Criteria

• Patients with unstable medical conditions that might make TMS unsafe. This includes current poorly controlled seizures.
• Ferromagnetic metal in the head.
• Pregnant.
• Currently active substance abuse except tobacco.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent of depression responders	From baseline to 1 week immediately after treatment week	Number of patients with \>50% improvement in Phq-9 scores before and then after 5 days of treatment
Improvement in Depression Symptoms	From baseline to 1 week immediately after treatment week	Change in Phq-9 ratings from baseline to end of treatment

Trial Locations

Locations (1)

Medical Univerity of South Carolina; 🇺🇸 Charleston, South Carolina, United States