Clinical trial NCT06748209: Establishing Mobile Transcranial Magnetic Stimulation
Official title: Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Treatment Resistant Major Depression
Keywords: Anxiety
Depression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mobile TMS qualifies as a Phase IV trial because it assesses the real-world efficacy of TMS therapy when administered via a mobile unit.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent of depression responders
timeFrame: From baseline to 1 week immediately after treatment week
measure: Improvement in Depression Symptoms
timeFrame: From baseline to 1 week immediately after treatment week
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical Univerity of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Mark George, MD
role: PRINCIPAL_INVESTIGATOR
References: