Establishing Mobile Transcranial Magnetic Stimulation

NCT ID: NCT06748209

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-10
• Study Completion Date: 2028-03-01

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.

Conditions

Treatment Resistant Major Depression

Study Design

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

Study Groups

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.

Group Type: OTHER

Left prefrontal Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

FDA cleared TMS

FDA cleared TMS for treating depression

Intervention Type: DEVICE

This is FDA approved TMS

Interventions

Left prefrontal Transcranial Magnetic Stimulation (TMS)

FDA cleared TMS

Intervention Type: DEVICE

FDA cleared TMS for treating depression

This is FDA approved TMS

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Mark George

Professor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark George, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical Univerity of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark S George, MD

Role: CONTACT

GEORGEM@MUSC.EDU

8438765142

Alexandra Herron, BA

Role: CONTACT

herronal@musc.edu

Facility Contacts

Mark S. George, MD

Role: primary

GEORGEM@MUSC.EDU

8438765142

Other Identifiers

Pro00139739

Identifier Type: -

Identifier Source: org_study_id