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Recruiting NCT06748209

Establishing Mobile Transcranial Magnetic Stimulation

Phase IV Interventional Treatment Resistant Major Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Left prefrontal Transcranial Magnetic Stimulation (TMS), FDA cleared TMS for treating depression.
Who it may be relevant to
Registry conditions: Treatment Resistant Major Depression. Basic parameters: 22 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Left prefrontal Transcranial Magnetic Stimulation (TMS)
    FDA cleared TMS
  • Device FDA cleared TMS for treating depression
    This is FDA approved TMS

Primary outcome measures

  • Percent of depression responders [Time frame: From baseline to 1 week immediately after treatment week]
  • Improvement in Depression Symptoms [Time frame: From baseline to 1 week immediately after treatment week]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medical Univerity of South Carolina — Charleston

Identifiers

NCT: NCT06748209 · Pro00139739

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗