Establishing Mobile Transcranial Magnetic Stimulation (TMS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Treatment Resistant Major Depression
• Intervention / Treatment: Device: Left prefrontal Transcranial Magnetic Stimulation (TMS); Device: FDA cleared TMS for treating depression

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mark S George, MD; Phone Number: 8438765142; Email: GEORGEM@MUSC.EDU
• Study Contact Backup: Name: Alexandra Herron, BA; Email: herronal@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical Univerity of South Carolina
      • Contact: Mark S. George, MD; Phone Number: 8438765142; Email: GEORGEM@MUSC.EDU

Participation Criteria

Eligibility Criteria

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

Description

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 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
Other: Open label Clinical TMS for Depression; This will be FDA approved Left Prefrontal TMS for treating depression, we will be performing this within a VA, located at clinics throughout SC.	Device: Left prefrontal Transcranial Magnetic Stimulation (TMS); FDA cleared TMS; Device: FDA cleared TMS for treating depression; This is FDA approved TMS

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Mark George, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression
• Other Study ID Numbers: Pro00139739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: age, gender, degree of treatment resistance, current medications, changes in depression scores
• IPD Sharing Time Frame: After conclusion of the study and for 5 years after publication.
• IPD Sharing Access Criteria: All credible investigators, by writing and asking permission from the study PI and team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes