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Establishing Mobile Transcranial Magnetic Stimulation

NCT06748209 · Medical University of South Carolina
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression
About this study
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.
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.
Study design
Enrollment target: 30 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-10
Estimated completion: 2028-03-01
Last updated: 2025-05-31
Interventions
Device: Left prefrontal Transcranial Magnetic Stimulation (TMS)Device: FDA cleared TMS for treating depression
Primary outcomes
  • Percent of depression responders (From baseline to 1 week immediately after treatment week)
  • Improvement in Depression Symptoms (From baseline to 1 week immediately after treatment week)
Sponsor
Medical University of South Carolina · other
Contacts & investigators
ContactMark S George, MD · contact · GEORGEM@MUSC.EDU · 8438765142
ContactAlexandra Herron, BA · contact · herronal@musc.edu
InvestigatorMark George, MD · principal_investigator, Medical University of South Carolina
All locations (1)
Medical Univerity of South CarolinaRecruiting
Charleston, South Carolina, United States
Establishing Mobile Transcranial Magnetic Stimulation · TrialPath