Establishing Mobile Transcranial Magnetic Stimulation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Medical Univerity of South Carolina — Charleston

Идентификаторы

NCT: NCT06748209 · Pro00139739

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗