Medical Univerity of South Carolina
Charleston, South Carolina, 29425, United States
Location status: Recruiting
NCT Number: NCT06748209
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.
Interested in participating?
Request Info22 year–80 year
All sexes
Interventional
Phase 4
Charleston, South Carolina, 29425, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FDA cleared TMS
This is FDA approved TMS
Time frame: 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
Time frame: From baseline to 1 week immediately after treatment week
Change in Phq-9 ratings from baseline to end of treatment
Contact information is provided by the study sponsor or research team.
Alexandra Herron, BA
CONTACT
Mark S George, MD
CONTACT
Medical University of South Carolina
Other
Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression
Acronym: TMS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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